Northwest Louisiana Nephrology

Center Information

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

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

Center Overview

Northwest Louisiana Nephrology is a full time private practice clinic with 8 full time and 2 part-time practicing Physicians of which all 10 are Board Certified in Internal Medicine and Nephrology, the practice has 4 Certified Family Nurse Practitioners, 2 Certified Acute Care Nurse Practitioners and 2 Physician Assistants Certified. The practice has 2 office clinics and 1 satellite clinic in the surrounding ARKLATEX areas. The Physicians are Medical Directors of 21 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 5 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 10 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, and 1 full time Study Staff CNSS, CITI trained.

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.

Performance Metrics

Number of Studies Conducted: 94
Number of Studies Actually Completed: 79
Number of Active Patients in the Database: 10,000
Regulatory Submission Turn-Around Time: 3 Week(s)
Average Number of Total Patients Enrolled: 60
Average Percent of Total Patients Randomized: 98%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 100%
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

Clinical Research 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
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
CROs
  • Accelovance
  • Averion
  • Care Stat
  • Chiltern
  • Clinipace
  • Covance
  • Frenova
  • ICON
  • nTouch Research
  • Paraxel
  • PPD
  • PRA International
  • Quintiles
  • Spectrum
LABORATORY
  • Covance
  • ICON
  • Qunitiles
  • Medpace
  • Quest
EDC
  • Medidata Rave
  • iMedidata
  • Inform
  • Clinipace
  • Viedoc
  • Oracle RDC
  • Clin Trak
RESEARCH EXPERIENCE SINCE 2001
  • 8 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
  • 1 CFNP & 1 PA full time Hospital Night call
  • 1 Full-time, Manager/SC- BSN, RN, CCRC
  • 1 Full-time SC - RMA CCRC
  • 1 Full time SC- CNSS, CAN
STUDY EXPERIENCE
  • Phase I, II, III, and IV Clinical Trials
CENTRAL IRB
  • Schulman
  • CGIRB Connexus WIRB
  • Quorum
  • Sterling
  • NEIRB
  • Salus IRB
  • IntegReview
  • Chesapeake

Facility Description

Northwest Louisiana Nephrology has been in private practice for the past 30 years. The practice has expanded over the years to include 10 nephrologists, and are board certified, 1 MD is a CPI and member of ACRP, 3 CFNP, 2 ACNP, 2 PA, 1 RN (CCRC), (current member with ARCP), 1 RMA CCRC (current member of ACRP.

2 office clinics, a Transplant clinic and 1 satellite clinic. The Physicians are affiliated with 5 hospitals and 5 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 Experience

Philip J. Garavaglia, M.D.
American Board of Internal Medicine, and Nephrology Sub-specialty
16 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
18 years research experience, CITI certified

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

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

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

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

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

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

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

Srinivasa R. Iskapalli M.D.
American Board of Internal Medicine and Nephrology Sub-specialty
3years experience and CITI Certified

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

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

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

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

Cassie Miller, PAC
2 years research experience CITI certified

Staff Expertise

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

Deanna Ferrell, CCRC
Research Coordinator
10 years of clinical research

Jacinta Lewis, CAN, CNSS
CITI Certified
1 years of clinical research

RESEARCH STUDIES:

November 2001- December 2001 Prevalence of Anemia in Patients With Early Renal Insufficiency
Protocol PR99-06-002
Ortho Biotech, Inc.
November 2001 – November 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.
3 Year Study
April 2002– September 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
28 Week Study
May 2002– September 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
28 Week Study
May 2002– June 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
28 Week Study
July 2002– January 2006 Correction 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 with Anemia due to Chronic Kidney Disease”. PROMPT
Protocol PR01-06-021
Ortho Biotech Products, L.P.
16 Week Study
August 2002- October 2004 A Study of the Efficacy and Safety of Venofer [ Iron Sucrose Injection] in Anemic Patients Receiving Peritoneal Dialysis
Protocol 1VEN02021
Luitpold
71 Day Study
March 2003- December2004 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.
10 Week Study
March 2003-January 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.
10 Week Study
July 2003- October 2006 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
58 Weeks Study
November 2003—2004 CONTROL, Cinacalcet, Open Label Study to Reach K/DOQI Level Phase 2;
Protocol # AMG-073 2002
Amgen
52 week study
July 2003-December 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
33 Weeks Study
November 2003 – 2004 TARGET Treatment Strategies to Achieve Recommended K/DOQI Goals in ESRD Patients on Cinacalet
Phase II
Protocol #AMG-073 20020390
Amgen
52 week study
May 2004- October 2006 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.
35 day study
August 2004-2009 TREAT- Trial to Reduce Cardiovascular Events with Aranesp Therapy
Protocol 20010184
Amgen
4 year Study
November 2004- December 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
425 day Study
August 2004-May 2006 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
Phase IV
Abbott SEEK
Abbott Laboratories, Inc. 1 year
April 2004-July 2006 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.
53 week study.
July 2004-October 2005 Clinical Utility Of Caduet in Simultaneously achieving Blood Pressure and Lipid endpoints in a Specific Patients Population (CAPABLE)
Protocol A3841025
Pfizer
20 week study
April 2005 to 2007 A Randomized , Open-Label Study to Assess 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
Phase 3 – 56 weeks
December 2005 to 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
Amgen
Protocol 20050113
Phase 3 – 30 week study
March 2005 to July 2006 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
Novartis
MyTime
Protocol CERL080
September 2005 to 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
Speedel
ASCEND
Protocol SPP301CRD15
Phase 3 4 year study
July 2005 to 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
Luitpold
Protocol 1VIT04004 IND # 57,103
Phase 3 -56 days
Phase 3 – 56 days
October 2005 to 2006 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 Dependant (NDD) Chronic Kidney disease
(CKD)
Luitpold
Protocol VIT05005 – IND # 63,243
Phase 3 – 44 weeks
August 2005 to 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.
Shire
Protocol SPD 405-401
Phase 4 -13 weeks
March 2005 to 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
Roche
Protocol BH18387
Phase 3 – 104 Weeks
August 2005 to October 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
Abgenix
Protocol ABX-0504
Phase 1 -26 weeks
October 2005 to 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
Affymax
Protocol AFX01-03
Phase 2 - 15 weeks
August 2005- 2007 Dialysis patient’s Response to IV iron with Elevated Ferritin
DRIVE
Watson
Protocol FER0401
Phase IV 7-weeks
August 2005- 2007 Dialysis patient’s Response to IV iron with Elevated
Ferritin
DRIVE
Protocol FER0401
Watson
August 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
September 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
August 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
Watson
Protocol FER0601
August 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
September 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
September 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
July 2007- 2009 A Phase III, Open-label Study of Tenecteplase for
Restoration of Function in Dysfunctional Hemodialysis
Catheters
Protocol N3701g
Genentech
September 2007 – 2008 A Randomized Controlled Trial of the Effect if IV Iron
on Proteinuria in Non-Dialysis Chronic Kidney Disease
Patients
Protocol FER0701
Watson
October 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
October 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
February 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
February 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
March 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
August 2008- 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
July 2008 - April 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 Darbepotein Alfa
Protocol AFX01_202
Takeda
January 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 Epotein
Protocol AFX01_201
Takeda
April 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
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 – 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
December 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
April 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
December 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
August 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
April 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
October 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
April 2010 - 2012 A 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 - 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
August 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
March 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
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
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
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
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
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
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.
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.
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.
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.
Aug 2012 - 2015 START-CKD: Strategies Using Darbepoetin alfa to Avoid Transfusions in Chronic Kidney Disease
Protocol 20110226
Amgen
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 - 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.
Aug 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
Apr 2013 - 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.
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.
Jan 2014 - 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
Mar 2014 - 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
Dec 2013 - 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.
Jun 2014 - 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
Aug 2014 - Current 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
Protocol ZS005
ZS Pharma
Jun 2014 - Current 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.
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
Feb 2015- Current 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
Feb 2015- Current 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
Apr2015 - Feb 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
Jan 2015 - Current 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
Sep 2015- Current 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
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
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, 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-Current Phase3, 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 - 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
Mar 2016 - current 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.
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
Apr 2014 - Mar 2015 Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Protocol 90D0126
ZOLL

Patient Demographics

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 as outpatient or inpatient referrals.

Other Information

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 placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.