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

RESEARCH STUDIES:

November 2001- December 2001Prevalence of Anemia in Patients With Early RenalInsufficiency
Protocol PR99-06-002
Ortho Biotech, Inc.
November 2001 – November 2005A Randomized, Open Label, Parallel Design Study of RenagelPhosphate Binder Versus Calcium-Based Phosphate Binders inHemodialysis
Protocol GTC-68-401
GelTex Pharmaceuticals, Inc.
3 Year Study
April 2002– September 2002A Phase III Prospective, Randomized Placebo Controlled,Double-Blind Multi-Center Study to Evaluate the Safety and Efficacyof Zemplar Capsules in Reducing Serum Intact Parathyroid HormoneLevels in End Stage renal Disease Subjects on Hemodialysis
Protocol HD 2001-014
Abbott Laboratories
28 Week Study
May 2002– September 2002A Phase III Prospective, Randomized Placebo Controlled,Double-Blind Multi-Center Study to Evaluate the Safety and Efficacyof Zemplar Capsules in Reducing Serum Intact Parathyroid HormoneLevels in End Stage renal Disease Subjects on PeritonealDialysis
Protocol 2001-015
Abbott Laboratories
28 Week Study
May 2002– June 2003A Placebo-controlled, Double–blind, Multicenter Study to Assessthe Efficacy and Safety of an Oral Calcimimetic Agent ( AMG 073) inSecondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis)
Protocol AMG 073 20000188
Amgen
28 Week Study
July 2002– January 2006Correction of Hemoglobin and Outcomes in Renal Insufficiency“CHOIR”
Protocol PR00-06-014
Ortho Biotech Products, L.P.
3 Year Study
July 2002 – November 2003“A Randomized Open Label Clinical Evaluation for PROCRIT(Epoetin Alfa) for Maintenance Phase treatment of Patients withAnemia due to Chronic Kidney Disease”. PROMPT
Protocol PR01-06-021
Ortho Biotech Products, L.P.
16 Week Study
August 2002- October 2004A Study of the Efficacy and Safety of Venofer [ Iron SucroseInjection] in Anemic Patients Receiving Peritoneal Dialysis
Protocol 1VEN02021
Luitpold
71 Day Study
March 2003- December2004A Randomized, controlled, Open-Label Study of the Safety andEfficacy of Ferrlecit vs. Oral Iron in Iron Deficient Patients withChronic Kidney Disease Being Treated with Erythropoietictherapy
Protocol FER0201
Watson Laboratories, Inc.
10 Week Study
March 2003-January 2005A Randomized, controlled, Open-Label Study of the Safety andEfficacy of Ferrlecit vs. Oral Iron in Iron Deficient Patients withChronic Kidney Disease
Protocol FER0202
Watson Laboratories, Inc.
10 Week Study
July 2003- October 2006A prospective, randomized, double-blind, double-dummy,forced-titration, multicentre, parallel group, one year treatmenttrial to compare MICARDIS (telmisartan) 80mg versus COZAAR(losartan) 100mg in hypertensive type 2 diabetic patients withovert nephropathy (AMADEO Study)
Protocol 502.397
Boehringer Ingelheim
58 Weeks Study
November 2003—2004CONTROL, Cinacalcet, Open Label Study to Reach K/DOQI LevelPhase 2;
Protocol # AMG-073 2002
Amgen
52 week study
July 2003-December 2004A Randomized, Double-blind Study Comparing Aranesp (darbepoetinalfa) and Recombinant Human Erythropoietin in the treatment ofAnemia in African American Subjects with Chronic Renal Failure(CRF) Receiving Hemodialysis
Protocol Aranesp 20010125
Amgen
33 Weeks Study
November 2003 – 2004TARGET Treatment Strategies to Achieve Recommended K/DOQI Goalsin ESRD Patients on Cinacalet
Phase II
Protocol #AMG-073 20020390
Amgen
52 week study
May 2004- October 2006A Phase III, Study of the Safety and Efficacy of Two ParentalDose, Regimens of Ferumoxytol (compared with oral iron) as an IronReplacement Therapy in CKD Patients not on Dialysis
Protocol 62745-6
Advance Magnetics Inc.
35 day study
August 2004-2009TREAT- Trial to Reduce Cardiovascular Events with AranespTherapy
Protocol 20010184
Amgen
4 year Study
November 2004- December 2005A Phase III, Multicenter, Randomized, Placebo-Controlled,Double-Blinded Study to Evaluate Efficacy of StaphVAX, a BivalentStaphylococcus aureus Glycoconjugate Vaccine in Adults onHemodialysis.
Protocol NABI-1371
Nabi Biopharmaceuticals
425 day Study
August 2004-May 2006A Prospective Community Cohort Observational Study to Examinethe Prevalence of Abnormalities of Parathyroid Hormone, Calcium,Phosphorus and Vitamins in Patients with Chronic KidneyDisease
Phase IV
Abbott SEEK
Abbott Laboratories, Inc. 1 year
April 2004-July 2006A Phase III An open-label, randomized, multi-center, parallelgroup study to demonstrate correction of anemia using subcutaneousinjections of RO0503821 in patients with chronic kidney disease whoare not on renal replacement therapy
Protocol BA16738
Hoffmann-LaRoche Ltd.
53 week study.
July 2004-October 2005Clinical Utility Of Caduet in Simultaneously achieving BloodPressure and Lipid endpoints in a Specific Patients Population(CAPABLE)
Protocol A3841025
Pfizer
20 week study
April 2005 to 2007A Randomized , Open-Label Study to Assess the Safety of EpoetinAlfa Manufactured by Deep Tank Technology and Epoetin AlfaManufactured by Roller Bottle technology in Subjects with ChronicKidney Disease Not on Dialysis
Protocol 20040259
Amgen
Phase 3 – 56 weeks
December 2005 to 2007A randomized, Double-Blind, Equivalence Study of the Efficacyof Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology andEpoetin alfa Manufactured by Roller Bottle Technology for theTreatment of Anemia in patients with Chronic Kidney DiseaseReceiving Hemodialysis
Amgen
Protocol 20050113
Phase 3 – 30 week study
March 2005 to July 2006A three- month, open-label, two cohort study to investigate thesafety and tolerability of Myfortic in combination with Neoral orTacrolimus in renal transplant recipients with GI intolerance
Novartis
MyTime
Protocol CERL080
September 2005 to 2007Avosentan (SPP301)
Diabetic Nephropathy
A randomized, double blind, placebo controlled, parallel groupstudy to assess the effect of the Endothelin receptor antagonistavosentan on time to doubling of serum Creatinine, end stage renaldisease or death in patients with type 2 diabetes mellitus anddiabetic nephropathy
Speedel
ASCEND
Protocol SPP301CRD15
Phase 3 4 year study
July 2005 to 2006Comparison of the Safety and Efficacy of a Unique IntravenousIron Preparation (VIT-45) versus Oral Iron in the Treatment ofAnemia in Non-Dialysis Dependent Chronic Kidney Disease
Luitpold
Protocol 1VIT04004 IND # 57,103
Phase 3 -56 days
Phase 3 – 56 days
October 2005 to 2006Open Label Extension Evaluating the Long Term Safety,tolerability and Efficacy of an Iron Maintenance Dosing StrategyUtilizing Intravenous VIT-45 in the treatment of Anemia in theNon-Dialysis Dependant (NDD) Chronic Kidney disease
(CKD)
Luitpold
Protocol VIT05005 – IND # 63,243
Phase 3 – 44 weeks
August 2005 to 2006A Phase-IV, Open-Label, Multi-Center Trial Evaluating theEfficacy of Fosrenol Compared to Exiting Therapy in Adults with EndStage renal Disease treated for Hyperphosphatemia.
Shire
Protocol SPD 405-401
Phase 4 -13 weeks
March 2005 to 2010An Open-Label, Multi-Center study to Document the Efficacy,Safety and Tolerability of Long Term Administration of RO0503821 inPatients with Chronic Kidney Renal Anemia
Roche
Protocol BH18387
Phase 3 – 104 Weeks
August 2005 to October 2006A Double-Blind, Randomized, Placebo Controlled. Parallel Group,Multiple Dose Study to assess the Safety, tolerability,Pharmacokinetics and Pharmacodynamics of ABX10241 in HemodialysisSubjects with Secondary Hyperparathyroidism
Abgenix
Protocol ABX-0504
Phase 1 -26 weeks
October 2005 to 2007A Phase 2, Open-Label, Multi-Center, Sequential, Dose FindingStudy if the Safety, Pharmacodynamics, and Pharmacokinetics ofAF37702 Injection (Hematide) Administration Intravenously for theMaintenance Treatment of Anemia in Chronic Hemodialysispatients
Affymax
Protocol AFX01-03
Phase 2 - 15 weeks
August 2005- 2007Dialysis patient’s Response to IV iron with ElevatedFerritin
DRIVE
Watson
Protocol FER0401
Phase IV 7-weeks
August 2005- 2007Dialysis patient’s Response to IV iron with Elevated
Ferritin
DRIVE
Protocol FER0401
Watson
August 2006 - 2010An 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
September 2006 - 2007A 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
August 2006 - 2007A 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
Watson
Protocol FER0601
August 2006 – 2008A 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
September 2007 – 2010A 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
September 2007- 2010A 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
July 2007- 2009A Phase III, Open-label Study of Tenecteplase for
Restoration of Function in Dysfunctional Hemodialysis
Catheters
Protocol N3701g
Genentech
September 2007 – 2008A Randomized Controlled Trial of the Effect if IV Iron
on Proteinuria in Non-Dialysis Chronic Kidney Disease
Patients
Protocol FER0701
Watson
October 2007 – 2008A 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
October 2007 – 2009A 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
February 2008 – 2009Outcome 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
February 2008 - 2009A 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
March 2008 – 2009A 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
August 2008- 2011A 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
July 2008 - April 2010A 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 Darbepotein Alfa
Protocol AFX01_202
Takeda
January 2009 - 2010A Phase 2 Study of the Safety and Efficacy of AF37702
Injection for the Maintenance Treatment of Anemia in
Peritoneal Dialysis Subjects Previously Treated With Epotein
Protocol AFX01_201
Takeda
April 2009 – 2012A 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
January 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
December 2009 – 2010A 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
December 2009 – 2011Randomized Evaluation of efficacy and safety of Ferric
Carboxymaltose in Patients with iron deficiency Anemia and
Impaired Renal function.
REPAIR-IDA
Protocol 1VIT09030
Luitpold
April 2010 – 2011Ferumoxytol 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
December 2009 - 2011Randomized Evaluation of efficacy and safety of Ferric Carboxymaltose in Patients with iron deficiency Anemia and Impaired Renal function.
REPAIR-IDA
Protocol 1VIT09030
Luitpold
August 2009 - 2011A 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
April 2010 - 2011Ferumoxytol 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
October 2010 - 2012An 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
April 2010 - 2012A Phase 2, Randomized, Open-Label Active-Comparator (Epotein 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
August 2010 - 2013A 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
August 2010 - 2011A 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
March 2011 - 2012A 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
Nov 2011 - 2013Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type II Diabetes: The Occurrence of Renal Events (BEACON)
Protocol 402-C-0903
Reata Pharmaceuticals
Oct 2011 - 2012An 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
Jun 2011 - 2012Phase 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
Mar 2011 - 2013RADAR: 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
Nov 2011 - 2013A 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
Aug 2011 - 2014A 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.
Aug 2011 - 2014A 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.
Mar 2012 - 2013A 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.
Sep 2012 - 2014Open 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.
Aug 2012 - 2015START-CKD: Strategies Using Darbepoetin alfa to Avoid Transfusions in Chronic Kidney Disease
Protocol 20110226
Amgen
Jan 2013 - 2014A 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 - 2014Phase 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.
Aug 2013 - 2014A 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
Apr 2013 - 2015Randomized, 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.
Jul 2013 - 2014A 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.
Jan 2014 - 2015A 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
Mar 2014 - 2015An 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
Dec 2013 - 2015A 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.
Jun 2014 - 2015A 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
Aug 2014 - CurrentA 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
Protocol ZS005
ZS Pharma
Jun 2014 - CurrentA 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.
Apr 2014 - Mar 2015A 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
Feb 2015- CurrentA 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
Feb 2015- CurrentA 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
Apr2015 - Feb 2016A 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
Jan 2015 - CurrentA 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
Sep 2015- CurrentA 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
Nov 2015 - CurrentA 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
Nov 2015 - CurrentA 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
Dec 2015-CurrentPhase3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadaustat for the Maintenance Treatment of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease NDD-CKD)
Protocol : AKB-6548-CI-0015
Akebia
Dec 2015 - CurrentPhase3, 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
Mar 2016 - currentAn 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.
Jan 2016- Jun 2016A 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
Apr 2014 - Mar 2015Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Protocol 90D0126
ZOLL
Mar 2017 – Oct 2018A 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

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.