| 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-Current |
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-CurrenMay 2006t |
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 Current |
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
Phase 3 – 56 weeks |
| December 2005 to Current |
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 Current |
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 Current |
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 Current |
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 Current |
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 Current |
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 Current |
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- Current |
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- Current |
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 – Current |
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 – Current |
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 – Current |
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 – Current |
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 - Current |
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- current |
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 - Current |
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- current |
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- current |
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- current |
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 |
