Northwest Louisiana Nephrology, L.L.C.

Center Information

Yeona DaCosta-Auld
Research Coordinator
Northwest Louisiana Nephrology, L.L.C.
1800 Buckner Street, Suite C-120
Shreveport, LA 71101
318-220-9792
318-220-9794
yauld@nwln.com

Currently Enrolling Trials

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Therapeutic Areas

Endocrinology
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Vaccines

Performance Metrics

Number of Studies Conducted: 157
Number of Studies Actually Completed: 143
Number of Active Patients in the Database: 10,000
Regulatory Submission Turn-Around Time: 3 Week(s)
Average Number of Total Patients Enrolled: 200
Average Percent of Total Patients Randomized: 98%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 95%
EDC Capabilities: Yes

Staff Certifications
Number of Certified CRCs: 2
Number of Certified PIs: 1

ACRP Certifications
Number of ACRP Certified CRCs: 2
Number of ARCP Certified PIs: 1

Overview

Northwest Louisiana Nephrology L.L.C. is a full time private practice clinic with  9 full time and 2 part-time practicing Physicians of which all  11 are Board Certified in Internal Medicine and Nephrology, the practice has 4 Certified Family Nurse Practitioners, 2 Certified Acute Care Nurse Practitioners and  1  Physician Assistants Certified. The practice has 2 office clinics and 1 satellite clinic in the surrounding ARKLATEX areas. The Physicians are Medical Directors of  20 Hemodialysis units, 1 Peritoneal Dialysis unit. The practice also supports a Transplant Clinic and an Anemia Clinic. The practice is affiliated with 5 private hospitals and  2  LTAC facilities in Shreveport/ Bossier, and serves the citizens of the metropolitan area of Shreveport/ Bossier and Northwest Louisiana, East Texas, and Southeast Arkansas.

This practice has been participating in research since 2000, founded by the Nephrologists in this practice. The research department consists of   11 nephrologists, 3 serve as PI and 5 Sub I, the Nurse Practitioners and Physician Assistants also serve as Sub Is, 1 Full time RN, BSN CCRC Research Manager /Study Coordinator, 1 full time Study Coordinator RMA, CCRC, 

MISSION STATEMENT: To provide assured quality clinical research services and outcomes, thereby helping to show improvement in quality of life for patients with Chronic Kidney Disease, transplant, and HD/PD, dialysis.

  • Northwest Louisiana Nephrology has not had a FDA Audit
  • Northwest Louisiana Nephrology has had Sponsor Audits
  • Northwest Louisiana Nephrology is now a paperless site.  They are using a cloud based website software for Regulatory and source notes.  The two companies they are currently using are Complion for regulatory and CRIO for Source. Both are GCP compliant.

Experience

  • Anemia
  • Diabetes
  • Electrolyte Disorders
  • Glomerulonephritis
  • HD/PD studies
  • Hypertension
  • Kidney Stone Disease
  • Nephrology/ Acute and Chronic Renal Failure
  • Osteoporosis
  • Proternuria/Hematuria
  • Renal Transplantation
  • Secondary Hyperparathyroidism
  • Iron Deficiency
  • Hyperphosphatemia
  • FSGS
  • IgAN
  • Membranous Nephropathy
  • Diabetic Nephropathy
  • APKD

SPONSORS

  • Abbott Laboratories
  • ABBVIE
  • Abgenix
  • Advance Magnetics
  • Affymax
  • Akebia
  • AMAG
  • Amgen
  • Ardelyx
  • AstraZeneca
  • Bayer
  • Boehringer Ingelheim
  • Eli Lilly
  • FibroGen
  • GelTex Pharmaceuticals, Inc.
  • Gilead
  • GSK
  • Hospira
  • Kureha
  • Luitpold
  • Mitsubishi Tanabe Pharma
  • OPKO Health
  • Ortho Biotech
  • Pharmanet
  • Phosphate Therapeutic Ltd.
  • Roche
  • Speedel
  • Takeda
  • Watson
  • ZS Pharma
  • Apellis
  • Arunia
  • Alnylam
  • Reata
  • Metavant Sciences GmbH
  • CorMedix
  • ChemoCentryx
  • Sanifit
  • Pharmacosmos
  • Ironwood
  • Reata Pharmaceuticals
  • Shield Therapeutics LTD
  • COMPLEXA

CROs

  • Accelovance
  • Averion
  • Care Stat
  • Chiltern
  • Clinipace
  • Covance
  • Frenova
  • ICON
  • nTouch Research
  • Paraxel
  • PPD
  • PRA International
  • Quintiles
  • Spectrum
  • Biorasi
  • CTI Clinical Trials and Consulting
  • Medpace
  • IQVIA

LABORATORY

  • Covance
  • ICON
  • Qunitiles
  • Medpace
  • Quest
  • PPD
  • Spectra
  • Q2 LAB

EDC

  • Medidata Rave
  • iMedidata
  • Inform
  • Clinipace
  • Viedoc
  • Oracle RDC
  • Clin Trak
  • IBM

RESEARCH EXPERIENCE SINCE 2001

  • 9 full time and 2 Part time practicing Nephrologists
  • 2 CFNP & 1 ACNP Dialysis full time and Weekend Hospital rotation
  • 1 ACNP & 1 PA Clinic full time and weekend Hospital rotation
  • 2 CFNP & full time Hospital Night call
  • 1 Full-time, Manager/SC- BSN, RN, CCRC
  • 1 Full-time SC - RMA CCRC
  • STUDY EXPERIENCE •Phase I, II, III, and IV Clinical Trials

STUDY EXPERIENCE

  • Phase I, II, III, and IV Clinical Trials

CENTRAL IRB

  • Schulman
  • CGIRB Connexus WIRB
  • Quorum
  • Sterling
  • NEIRB
  • Salus IRB
  • IntegReview
  • Chesapeake
  • Advarra
  • Connexus
  • OnQPortal
  • CGIRB
  • Alpha

Facility

Northwest Louisiana Nephrology L.L.C. has been in private practice for the past  35 years. The practice has expanded over the years to include  11 nephrologists, all  board certified, 1 MD is a CPI and member of ACRP,  4 CFNP, 2 ACNP,  1  PA, 1 RN (CCRC), (current member with ARCP), 1 RMA CCRC (current member of ACRP.

2 office clinics, a Transplant clinic and  2  satellite clinic. The Physicians are affiliated with 5 hospitals and  2  LTACs hospital serving the population with both outpatient/inpatient services. Research is conducted at the Buckner Clinic, and HD/PD centers.

Our facility is 20 minutes form the Shreveport Regional Airport. We are within 5-30 minutes from 7 HD/PD centers and hospitals and 30-90 minutes from 12 HD centers. The Research office is within 10-15 minutes from major hotels and we have the major rent-a car companies or the use of cabs.

Our practice has dedicated area for research and is equipped with a phone line for computer and personal phones. Additionally, we have an EKG machine, vital checks, Lab with refrigerated centrifuge, refrigerator for medication and -20 degrees freezer, and availability to dry ice.

Investigator

Philip J. Garavaglia, M.D.
American Board of Internal Medicine, and Nephrology Sub-specialty
18 years research experience and CITI certified

Raja I. Zabaneh, M.D., F.A.C.P., FASN
American Board of Internal Medicine, and Nephrology Sub-specialty
20 years research experience, CITI certified

Marwan O. Kaskas, M.D., FASN, CPI
American Board of Internal Medicine and Nephrology Sub-specialty
20 years research experience and CPI Certification, GCP certified

Curriculum Vitae for Marwan O. Kaskas

Sylvia D. Noble, M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
18 years research experience, CITI Certification

Stephen R. Patton, M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
18 years research experience and CITI certified

Michael D. Rokaw, M.D., FASN FACP
American Board of Internal Medicine and Nephrology Sub-specialty
25 years research experience and CITI certified

Arnold E. Barz, M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
18 years research experience and CITI certified

Sreedhara B. Alla, M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
10 years experience and CITI Certified

Zulqarnain A. Abro M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
9 years experience and CITI Certified

Srinivasa R. Iskapalli M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
5 years experience and CITI Certified

Patricia T Kennedy ARPN, CFNP
13 years research experience , CITI Certified

Audrey Rachal Smith APRN, ACNP
9 years research experience, CITI Certified

Mary Mladenka-Dowden APRN, CFNP
8 years research experience, CITI Certified

Kelli F. Jacob APRN, ACNP
5 years research experience CITI Certified

Cassie Miller, PAC
4 years research experience CITI certified

Cheng Chu M.D.- American Board of Internal Medicine and Nephrology Sub-specialty 2 years’ experience and CITI Certified

Staff

Yeona DaCosta-Auld, RN BSN, CCRC
Research Coordinator-, Administrative Manager
18 years of clinical research

Curriculum Vitae for Yeona M. DaCosta

Deanna L. Mondero RMA, CLP, CCRC
Research Coordinator
12 years of clinical research

Curriculum Vitae for Deanna L. Mondero

 

STUDIES CONDUCTED AT NORTHWEST LOUISIANA NEPHROLOGY  RESEARCH

Apr 2019 – Current

A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease . RTA 402-C-1808, Reata Pharmaceuticals

Mar 2019 –Current

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy. Protocol No. ALN-CC5-005, Alnylam Pharmaceuticals 

Mar 2019 – Current

An Open Label Dose-Exploration Cohort Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis.  Protocol No AUR-VCS-2017-03. AURONA  Aurinia Pharmaceuticals

Oct 2018 - Current

A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS).

Protocol CXA-10-2014,  Complexa Inc.

Aug 2018 - Current

A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL-2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease). Protocol No: APL2-201, Apellis Pharmaceuticals

Aug 2018 – Current

An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome. Protocol Number: CL012_140, ChemoCentryx

Apr 2018 – Current

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) Protocol Number: CL011_140, ChemoCentryx

Mar 2018 – Current  

Randomised, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 4 multiple rising oral doses of BI 685509 over 28 days in male and female patients with diabetic nephropathy. Protocol 1366-0004, Boehringer Ingelheim

Jan 2018 – Current

A 26‐Week, Phase 3, Open Label Study with a 12‐Week, Placebo‐Controlled, Randomized Withdrawal Period Followed by an Open Label Long Term Safety Open Label Long Term Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in End‐Stage Renal Disease Patients on Renal Disease Patients on Dialysis. Protocol Number: TEN-02-301, Ardelyx, Inc.

Nov 2016 – Current

Phase 3, randomized, open-label, active-controlled study evaluating the efficacy and safety of oral vadadustat for the maintenance treatment of anemia in subjects with dialysis-dependent chronic kidney disease (DD-CKD) (INNO2VATE-CONVERSION)

AKB-6548-CI-0017, Akebia, Phase 3

Dec 2015 - Current

Phase3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the  Correction Treatment of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease NDD-CKD), Protocol : AKB-6548-CI-0014, Akebia

Dec 2015 - Current

Phase3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the  Maintenance Treatment of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease NDD-CKD), Protocol : AKB-6548-CI-0015, Akebia

Nov 2015 - Current

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event- driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease, Protocol BAY94-8862 (finerenone)/16244  FIDELIO-DKD, Bayer HealthCare

Jun 2017 – Current

RENal hemodialysis patients ALlocated apixaban versus warfarinin Atrial Fibrillation (RENAL -AF) Randomized Clinical Trial, CV185-450, RENAL –AF, Phase 4

Mar 2017 – Current

A double-blind, randomised, placebo-controlled study to assess the effect of SNF472 on progression of cardiovascular calcification on top of standard of care in end-stage-renal-disease (ESRD) patients on haemodialysis (HD), SNFCT2015-05, Sanifit, Phase 2b

Aug 2018 – Apr 2019

A Phase 1b Partially-Blinded (sponsor unblind), Placebo-Controlled, Parallel Arm Study to Assess the Safety, Tolerability, and Pharmacokinetics of RVT-1501 (imeglimin) in Subjects with Type 2 Diabetes Mellitus and Moderate to Severe Chronic Kidney Disease. Protocol RVT-1501-1002,  Metavant Sciences GmbH

Dec 2017 – Apr 2019

A Phase 2 trial of the safety and efficacy of Bardoxolone Methyl in patients with rare chronic kidney diseases.  402-C-1702.  REATA Pharmaceuticals

Aug 2017 – Mar 2019  

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lesinurad 200 mg in Combination With a Xanthine Oxidase Inhibitor (XOI), Compared With an XOI Alone, in Subjects With Gout and Estimated Creatinine Clearance 30 to <60 mL/min Who Have not Achieved Target Serum Uric Acid Levels on an XOI Alone. RDEA594-401, Ironwood Pharmaceuticals

Feb 2017 – May 2019

A phase 3, prospective, multicenter, double-blind, randomized, active control study to demonstrate the safety and effectiveness of Neutrolin® in preventing catheter-related bloodstream infections in subjects receiving hemodialysis therapy as treatment for end stage renal disease, LOCK-IT-100, CorMedix

Apr 2015 – Apr 2019

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in  Chronic Kidney Disease Patients not on Dialysis, Protocol D5740C00001, AstraZeneca

Feb 2015- Apr 2019

A Phase 3, Open-Label, Randomized , Open-Label,  Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the  Treatment of Anemia in Incident Dialysis Patients

Protocol FCGL-4592-63  Himalayas, FibroGen

Feb 2015- Apr  2019

A Phase 3, Open-Label, Randomized , Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects with Endstage Renal Disease (ESRD) on Stable Dialysis, Protocol FGCL-4592-064  Sierras, FibroGen

Feb 2015- Jan 2019

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat(Fg-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis, Protocol FGCL-4592-060  Andes, FibroGen

Jun 2017 – Nov 2018

An open-label, multicentre, extension trial to assess the safety of redosing of intravenous iron isomaltoside (Monofer®), P-Monofer-IDA/CKD-EXT-01, Phase 3

Mar 2017 – Oct 2018

A multicenter, open-label study to evaluate the efficacy and safety of glecaprevir/pibrentasvir in renally-impaired adults with chronic hepatitis c virus genotype 1-6 infection (expedition-5), M16-127, AbbVie, Phase 3b

Nov 2015 – Jul 2018

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event- driven Phase III study to investigate the efficacy and safety of finerenone, on the reduction of cardiovascular morbidity and mortality  in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease in addition to standard of care, Protocol BAY94-8862 (finerenone)/17530  FIGARO-DKD, Bayer HealthCare

Mar 2016 – Feb 2017

An 8 week, Multicenter, Randomized, Double blind, Parallel Group Study with a 4- week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety and Tolerability of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ERSD-HD), Protocol TEN -02-201, Ardelyx, Inc.

Feb 2017 – Nov 2018

A phase 3, Randomized. Placebo Controlled, Prospective, Multicenter Study with Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects with Chronic Kidney Disease ST10-01-303 AEGIS CKD, Shield Therapeutic LTD

Jan 2017- Nov 2018

A phase 3, randomised, open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (Monofer®) and iron sucrose in subjects with iron deficiency anaemia and non-dialysis-dependent chronic kidney disease, P-Monofer-CKD-04, Pharmacosmos

Jan 2017 – Nov 2017

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A 2 Part Prospective Study of H.P. Acthar® Gel (PODOCYTE)

MNK14224049, Mallinckrodt

Dec 2016 – Oct 2018

A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)- Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine, CL010_168, ChemoCentryx

May 2016- Jun 2016

Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study

Protocol 90D0126, ZOLL

Jan 2016-  Jun 2016

A 29-day, randomized, double-blinded, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety and pharmacokinetics of three-time weekly dosing of GSK1278863 in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who are switched from a stable dose of an erythropoiesis-stimulating agent

Protocol 204836, GSK

Jan 2015 - 2016

A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis, Protocol CL003_168, ChemoCentryx

Sep 2015 – Feb 2015

A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving  Hemodialysis, Protocol 17C-MC-FEAC(a), Eli Lilly and Company

Apr 2014- Mar 2015

A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of PT20 in Subjects with Hyperphosphataemia and Dialysis-Dependent Chronic Kidney Disease, Protocol PT20-120, Phosphate Therapeutics

Jun 2014 – Nov 2016

A Phase 2 Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, , Safety, and tolerability of GS-4997 in Subjects with Diabetic Kidney Disease, Protocol GS-US-223-1015, Gilead  Sciences,  Inc.

Aug 2014- Mar 2017

A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate), an Oral Sorbent, in Subjects With Hyperkalemia, including a Randomized, Double-blind, Placebo-controlled, Withdrawal Study  IND 108951, Protocol ZS005, ZS Pharma

Jun2014- Oct 2015

 A 24 Week, Phase 2B, randomized, active controlled parallel group, multi-center study to evaluate the safety and efficacy of GSK 127886 in Subjects with Anemia associated with Chronic Kidney  Disease who are not on dialysis, Protocol PHI113747,GlaxoSmithKline

Dec 2013- Aug 2015

A Long -term Safety and Efficacy Study of CTAP101 Capsules in Subjects with Stages 3 or 4 Chronic Kidney Disease, Secondary Hyperparathyroidism and Vitamin D Insufficiency (Extension of Study CTAP101-CL-3001 or CTAP101-CL-3002), Protocol CTAP101-CL-3003, OPKO Health, Inc.

Mar 2014- Oct 2015

An open Label Extension to Study ZS-004, a Phase 3 Multicenter, Multi-phase, Multi Dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study to Investigate the Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate), an Oral Sorbent, in Subjects with Hyperkalemia, Protocol ZS-004E, ZS Pharma

Jan 2014- Oct 2015

A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects with Chronic Kidney Disease on Hemodialysis, Protocol 20120231, AMGEN

Jul 2013 -2014

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects with Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency, Protocol  CTAP101-3001, OPKO Health, Inc.

Apr 2013 - Mar 2015

Randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease, Protocol HX575-307 Access, Sandoz Biopharmaceuticals Inc.

Apr 2013 - 2014

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis, Protocol 20120230  AMG 416, AMGEN

 

 

Aug 2012 -2014

“Phase 2B Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Pharmacodynamic Response, Safety, and Tolerability to 20 Weeks of Oral Dosing of AKB-6548 in Subjects with Anemia Secondary to Chronic Kidney Disease(CKD), GFR Categories G3A-G5 (stages 3,4, and 5) (Pre-Dialysis), Protocol AKB-6548-CI-0007, Akebia Therapeutics, Inc.

Jan 2013  - 2014

A Phase III Multicenter, Two-Phase, Multi-Dose, Prospective, Randomized, Double- blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicated), an Oral Sorbent, in Subject with Mild to Moderate Hyperkalemia, Protocol ZS-003, ZS Pharma, Inc.

Aug 2012 - 2015

START-CKD: Strategies Using Darbepoetin alfa to Avoid Transfusions in Chronic Kidney Disease, Protocol  20110226, Amgen

Sep 2012 -  2014

Open Label Uncontrolled Extension Study  of Soluble Ferric Pyrophosphate(SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis, Protocol   RMTI-SFP-6 Addendum, Rockwell Medical Tech., Inc.

Mar 2012 - 2013

A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate(SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis, Protocol  RMTI-SFP-6, Rockwell Medical Tech., Inc.

Aug 2011 - 2014

A Therapeutic-Equivalence Study Comparing the Efficacy and Safety of Subcutaneous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients with Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment, Protocol  EPOE-10-13, Hospira Inc.

Aug 2011 - 2014

A Therapeutic-Equivalence Study Comparing the Efficacy and Safety of Intravenous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients with Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment, Protocol  EPOE-10-01, Hospira Inc.

Nov 2011 - 2013

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blinded, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects with Autosomal Dominant Polycystic Kidney Disease, Protocol 156-09-290, Otsuka Pharmaceuticals  

Mar 2011 - 2013

RADAR: Reducing Residual Albuminuria in Subjects with Diabetes and Nephropathy with Atrasentan- A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety and Efficacy, Protocol M11-350, Abbott

Jun 2011 - 2012

Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamics Response, Pharmacokinetics, Safety, and Tolerability of 42-day Repeat Oral Doses of AKB-6548 in Subjects with Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4, Protocol AKB-6548-CI-005, Akebia Therapeutics

Oct 2011 - 2012

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 study to Investigate the Safety and efficacy of PA21 Compared with Sevelamer Carbonate Followed by a Randomised Comparison of PA21-Maintenance Dose Versus PA21-Low Dose in Dialysis Patients with Hyperphosphatemia, Protocol PA-CL-05A, Vifor Pharma

Nov 2011 - 2013

Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type II Diabetes: The Occurrence of Renal Events (BEACON),Protocol 402-C-0903, Reata Pharmaceuticals

Mar 2011 - 2012

A Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Efficacy of KAI-4169 in Hemodialysis Subjects with Secondary Hyperparathyroidism, Protocol KAI -4169-003, KAI Pharmaceuticals

Aug 2010 – 2011

A Double-Blind, Randomized, Placebo-Controlled Two- Period Crossover Study to Assess the Safety and Tolerability of Single Ascending Doses of KAI-4169 in Hemodialysis Subjects with Secondary Hyperparathyroidism  (Phase I), Protocol KAI-4169-002, KAI Pharmaceuticals

Aug 2010 - 2013

A Phase 2, Randomized, Open Label, Dose Titration, Efficacy and Safety Study of FG-4592 in Non-Dialysis Chronic Kidney Disease patients with Anemia, Protocol FGCL-4592-041, FibroGen

Apr  2010 – 2012

A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Double-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects with End-Stage Renal Disease Receiving Maintenance Hemodialysis.

Protocol FGCL-4592-040, FibroGen

Oct 2010- 2012

An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine ( Engerix-B®) among Adults (18 to 75 Years of Age) with Chronic Kidney Disease (CKD), Protocol DV2-HBV-17, Dynavax

Apr 2010 – 2011

Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, trail of Ferumoxytol Compared to Iron Sucrose for the Treatment of IRON Deficiency Anemia in Adult Subjects with Chronic Kidney  Disease, Protocol  FER-CKD-201, AMAG

Aug 2009 – 2011

A phase III, randomized, double-blind, placebo-controlled, parallel group, safety and efficacy study of BI 11356 95mg), compared to placebo as add on to pre-existing  antidiabetic therapy (insulin or any combination with insulin; sulphonylurea or glinides as monotherapy; pioglitazone or any other antidiabetics, excluding only DPP-4 inhibitors other than BI 1356) over 52 weeks in type 2 diabetic patients with severe chronic renal impairment, Protocol 1218.43, Boehringer, Ingelheim

Dec 2009 – 2011

Randomized Evaluation of efficacy and safety of Ferric Carboxymaltose in Patients with iron deficiency Anemia and Impaired Renal function, REPAIR-IDA, Protocol 1VIT09030, Luitpold

Dec 2009 – 2010

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study of the  Pharmacokinetics and Safety of Escalating Dose Levels of FG-4592 in Subjects with End-Stage Renal Disease Receiving Maintenance Hemodialysis, Protocol FGCL-4592-039, FibroGen

Jan 2009 – 2010

“A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biological Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects with Chronic Kidney Disease”, Protocol FGCL-SM4592-017, FibroGen

Apr 2009 – 2012

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease, Protocol KRM-306, EPPIC, Mitsubishi Tanabe – Kureha

Jan 2009 -  2010

A Phase 2 Study of the Safety and Efficacy of AF37702 Injection for the  Maintenance Treatment of Anemia in Peritoneal Dialysis Subjects Previously Treated With Epoetin, Protocol AFX01_201, Takeda

Jul 2008 - Apr 2010

A Phase 2 Study and Efficacy of AF37702 Injection for the  Maintenance Treatment of Anemia in Subjects with Chronic Renal Failure who Are on Hemodialysis or Do Not  Require Dialysis and Previously Treated With Darbepoetin Alfa, Protocol AFX01_202, Takeda

Aug 2008- Jan 2011

A 30-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects with Stage 3 Chronic Kidney Disease, Protocol M10-313, Abbott

Mar 2008 – 2009

A Randomized, Open-label, Multicenter, Study of Epoetin Alfa Comparing Two Extended Dosing regimens, Once Every Two Weeks and Once Every Four Weeks, with the Once Weekly dosing Regimen for Maintenance Treatment in Anemia Subjects With Chronic Kidney Disease

Protocol EPO-AKD-3002, Johnson & Johnson Pharmaceuticals

Feb 2008 - 2009

A Multi-center, Randomized Double-Blind, Active controlled Clinical trial to Evaluate the Safety and Tolerability of 24 weeks treatment with Vildagliptin (50mg qd) versus Sitagliptin (25mg qd) in patients with type 2 diabetes and severe renal insufficiency

Protocol: CLAF237A23138, Novartis

Feb 2008 – 2009

Outcome trial Evaluating the Efficacy and Safety of Norditropin in Adult Patients on Chronic Hemodialysis.  A Randomized , Double-blind, Parallel group, Placebo controlled, Multi-centre Trial, Protocol  NN1630-1453- OPPORTUNITY, Novo Nordisk

Oct 2007 – 2009

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects with Lupus Nephritis in Combination with Mycophenolate Mofetil therapy, Protocol  ZGI 493G01 MSEO28113, ZymoGentics

Oct 2007 – 2008

A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability on Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in treating iron Deficiency Anemia in Chronic Kidney Disease patients, Protocol 1VIT07018, Luitpold

Sep 2007 – 2008

A Randomized Controlled Trial of the Effect if IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients, Protocol FER0701, Watson

Jul 2007- 2009

A Phase III, Open-label Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters, Protocol N3701g, Genentech

Sep 2007- 2010

A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated  with Epoetin Alfa, Protocol: AFX01-12, Affymax

Sep 2007 – 2010

A Phase 3, Randomized, Active-Controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Correction of Anemia in the Patients with Chronic Renal Failure (CRF) not on Dialysis and not Erythropoiesis Stimulating Agent (ESA) Treatment, Protocol AFX01-11, Affymax

Aug 2006 – 2008

A 4-week, multicenter, double-blind, randomized, parallel group study to compare the gastrointestinal safety and tolerability of myfortic and MMF 9Cellcept) when administered in combination with calcineurin inhibitors in renal transplant recipients experiencing gastrointestinal intolerance, Protocol CERL080AUS51, Novartis

Aug 2006 - 2007

A Randomized Cross-Over Pilot Study of  the Effect of Sodium Ferric Gluconate  Complex vs. Iron Sucrose on Proteinuria  in Non-Dialysis Chronic Kidney Disease Patients, Protocol FER0601, Watson

Sep 2006 - 2007

A Randomized Study of the Safety and  Efficacy of FG-2216 in Subjects with Renal Anemia Not Requiring Dialysis and  Not Receiving Recombinant Human Erythropoietin

FibroGen, Protocol, FGCL-SM2216-019

Aug 2006 - 2010

An Open –label, Multi-center, Extension  Study to Evaluate the Safety and Tolerability of AF37702 Injection (Hematide™) for the Long-Term Maintenance treatment of Anemia in Patients With Chronic Kidney Disease, Protocol AFX01-09, Affymax

Mar 2006 - 2009

A Phase 2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of TBC3711 in Subjects with Resistant Hypertension, Protocol GRH01, Encysive

Aug 2005- 2007

Dialysis patient’s Response to IV iron with Elevated Ferritin

DRIVE, Protocol FER0401, Watson

Oct 2005 - 2007

A Phase 2, Open-Label, Multi-Center, Sequential, Dose Finding Study if the Safety, Pharmacodynamics, and Pharmacokinetics of AF37702 Injection (Hematide) Administration Intravenously for the  Maintenance Treatment of Anemia in Chronic Hemodialysis patients

Protocol AFX01-03, Affymax

Oct 2005 - 2007

A Phase 2, Open-Label, Multi-Center, Sequential, Dose Finding Study if the Safety, Pharmacodynamics, and Pharmacokinetics of AF37702 Injection (Hematide) Administration Intravenously for the  Maintenance Treatment of Anemia in Chronic Hemodialysis patients

Protocol AFX01-03, Affymax

Aug 2005 - 2006

A Double-Blind, Randomized, Placebo Controlled. Parallel Group, Multiple Dose Study to assess the Safety, tolerability, Pharmacokinetics and Pharmacodynamics of ABX10241 in Hemodialysis Subjects with Secondary Hyperparathyroidism, Protocol ABX-0504, Abgenix

Mar 2005 - 2010

An Open-Label, Multi-Center study to Document the Efficacy, Safety and Tolerability of Long Term Administration of RO0503821 in Patients with Chronic Kidney Renal Anemia, Protocol BH18387, Roche

Aug 2005 - 2006

A Phase-IV, Open-Label, Multi-Center  Trial Evaluating the Efficacy of Fosrenol Compared to Exiting Therapy in Adults with End Stage renal Disease treated for Hyperphosphatemia, Protocol SPD 405-401, Shire

Oct 2005 - 2007

Open Label Extension Evaluating the Long Term Safety, tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing Intravenous VIT-45 in the treatment of Anemia in the Non-Dialysis Dependent (NDD) Chronic Kidney disease (CKD), Protocol VIT05005 –Luitpold

Jul 2005 - 2006

Comparison of the Safety and Efficacy of a Unique Intravenous Iron Preparation (VIT-45) versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease, Protocol 1VIT04004, Luitpold

Sep 2005 - 2007

Avosentan (SPP301)Diabetic Nephropathy: A randomized, double blind, placebo controlled, parallel group study to assess the effect of the Endothelin receptor antagonist avosentan on time to doubling of serum Creatinine, end stage renal disease or death in patients with type 2 diabetes mellitus and diabetic nephropathy

Protocol SPP301CRD15 – ASCEND, Speedel

Mar 2005 -  2007

A three- month, open-label, two cohort study to investigate the safety and tolerability of Myfortic in combination with Neoral or Tacrolimus in renal transplant recipients with GI intolerance, Protocol CERL080 – MyTime, Novartis

Dec 2005 - 2007

A randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin alfa Manufactured by Roller Bottle Technology for the Treatment of Anemia in patients with Chronic Kidney Disease Receiving Hemodialysis, Protocol 20050113 Amgen

Apr 2005 – 2007

A Randomized , Open-Label Study to Asses the Safety of Epoetin Alfa Manufactured by Deep Tank Technology and Epoetin Alfa Manufactured by Roller Bottle technology in Subjects with Chronic Kidney Disease Not on Dialysis, Protocol 20040259, Amgen

Jul 2004- 2005

Clinical Utility Of Caduet in Simultaneously achieving Blood Pressure and Lipid endpoints in a Specific Patients Population (CAPABLE), Protocol A3841025, Pfizer

Apr  2004-2008

A Phase III A, Randomized Controlled Open Label, Multi-Center, Parallel Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered with Prefilled Syringes for the Maintenance Treatment of Anemia in Patients with Chronic Kidney Disease who are on Dialysis, Protocol BA16738, Hoffmann-LaRoche Ltd.

Apr 2004 – 2009

A Phase III An open-label, randomized, multi-center, parallel group study to demonstrate correction of anemia using subcutaneous injections of RO0503821 in patients with chronic kidney disease who are not on renal replacement therapy, Protocol BA16738, Hoffmann-LaRoche Ltd.

Aug  2004 - 2007

A Prospective Community Cohort Observational Study to Examine the Prevalence of Abnormalities of Parathyroid Hormone, Calcium, Phosphorus and Vitamins in Patients with Chronic Kidney Disease, Abbott SEEK, Abbott Laboratories, Inc.  1 year

Nov 2004-  2005

A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus aureus Glycoconjugate Vaccine in Adults on Hemodialysis, Protocol NABI-1371, Nabi Biopharmaceuticals

Aug  2004 - 2009

TREAT- Trial to Reduce Cardiovascular Events with Aranesp Therapy, Protocol 20010184, Amgen

May 2004- 2007

A Phase III, Study of the Safety and Efficacy of Two Parental Dose, Regimens of Ferumoxytol (compared with oral iron) as an Iron Replacement Therapy in CKD Patients not on Dialysis, Protocol 62745-6, Advance Magnetics Inc.

Nov 2003 – 2004

TARGET Treatment Strategies to Achieve Recommended K/DOQI Goals in ESRD Patients on Cinacalet Phase II, Protocol AMG-073 20020390, Amgen

Jul 2003- 2004

A Randomized, Double-blind Study Comparing Aranesp (darbepoetin alfa) and Recombinant Human Erythropoietin in the  treatment of Anemia in African American Subjects with Chronic Renal Failure (CRF) Receiving Hemodialysis, Protocol  Aranesp 20010125, Amgen

Nov 2003—2004

CONTROL,  Cinacalcet, Open Label Study to Reach K/DOQI Level Phase 2, Protocol  AMG-073 2002, Amgen

Jul 2003- 2005

A prospective, randomized, double-blind, double-dummy, forced-titration, multicentre, parallel group, one year treatment trial to compare MICARDIS (telmisartan) 80mg versus COZAAR (losartan) 100mg in hypertensive type 2 diabetic patients with overt nephropathy (AMADEO Study), Protocol 502.397, Boehringer, Ingelheim

Mar 2003- 2005

A Randomized, controlled, Open-Label Study of the Safety and Efficacy of Ferrlecit vs. Oral Iron in Iron Deficient Patients with Chronic Kidney Disease, Protocol FER0202, Watson Laboratories, Inc.

Mar 2003- 2004

A Randomized, controlled, Open-Label Study of the Safety and Efficacy of Ferrlecit vs. Oral Iron in Iron Deficient Patients with Chronic Kidney Disease Being Treated with Erythropoietic therapy, Protocol FER0201, Watson Laboratories, Inc.

Aug 2002-  2004

A Study of the Efficacy and Safety of Venofer [ Iron Sucrose Injection] in Anemic Patients Receiving Peritoneal Dialysis, Protocol 1VEN02021, Luitpold

Jul 2002 –  2003

“A Randomized Open Label Clinical Evaluation for PROCRIT (Epoetin Alfa) for Maintenance Phase treatment of Patients with Anemia due to Chronic Kidney Disease”.     PROMPT, Protocol PR01-06-021, Ortho Biotech Products, L.P.

Jul 2002 - 2006

Correction of Hemoglobin and Outcomes in Renal Insufficiency   “CHOIR”, Protocol PR00-06-014, Ortho Biotech Products, L.P.

May 2002 – 2003

A Placebo-controlled, Double–blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent ( AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease  (Hemodialysis and Peritoneal Dialysis), Protocol AMG 073 20000188, Amgen

May 2002 -  2002

A Phase III Prospective, Randomized Placebo Controlled, Double-Blind Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage renal Disease Subjects on Peritoneal Dialysis, Protocol   2001-015, Abbott Laboratories

Apr 2002– 2002

A Phase III Prospective, Randomized Placebo Controlled, Double-Blind Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage renal Disease Subjects on Hemodialysis, Protocol  HD 2001-014, Abbott Laboratories

Nov 2001 – 2005

A Randomized, Open Label, Parallel Design Study of Renagel Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis, Protocol GTC-68-401, GelTex Pharmaceuticals, Inc.

Nov 2001- 2001

Prevalence of Anemia in Patients With Early Renal Insufficiency, Protocol PR99-06-002, Ortho Biotech, Inc.

 

 

Patients

10,000 clinic patients
250 renal transplant patients
800 hemodialysis patients
40 peritoneal dialysis patients

The practice does see 1000 new patients per year either asoutpatient or inpatient referrals.

Other

Our site uses a Central IRBs

  • Aspire
  • WIRB
  • RCRC
  • NEIRB
  • Quorum
  • SAIRB
  • Chesapeake Research Review
  • Sterling IRB
  • Liberty IRB

Contact Center

If you are interested in contacting this center to discuss clinical trials, please complete and send the email form below. A representative from the research center will then follow up with you.