Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

PHASE3CompletedINTERVENTIONAL
Enrollment

823

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

January 31, 2010

Conditions
Chronic Renal FailureChronic Kidney DiseaseAnemia
Interventions
DRUG

peginesatide

"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."

DRUG

Epoetin alfa or Epoetin beta

"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."

Trial Locations (84)

1309

Research Facility, Sofia

1431

Research Facilities (2), Sofia

1527

Research Facility, Sofia

1606

Research Facility, Sofia

4000

Research Facility, Plovdiv

4003

Research Facility, Plovdiv

4400

Research Facility, Pazardzhik

5000

Research Facility, Veliko Tarnovo

5800

Research Facility, Pleven

7002

Research Facility, Rousse

8000

Research Facility, Burgas

9010

Research Facility, Varna

10461

Research Facility, The Bronx

11238

Research Facility, Brooklyn

11355

Research Facility, Flushing

13005

Research Facility, Ciudad Real

16507

Research Facility, Erie

19141

Research Facility, Philadelphia

20850

Research Facility, Rockville

22033

Research Facility, Fairfax

22100

Research Facility, Como

22297

Research Facility, Hamburg

23900

Research Facility, Lecco

26100

Research Facility, Cremona

28041

Research Facility, Madrid

28359

Research Facilities (2), Bremen

28801

Research Facility, Asheville

28922

Research Facility, Madrid

29118

Research Facility, Orangeburg

33000

Research Facility, Bordeaux

33156

Research Facility, Pinecrest

33173

Research Facility, Miami

33313

Research Facility, Lauderdale Lakes

34295

Research Facility, Montpellier

39008

Research Facility, Santander

39601

Research Facility, Brookhaven

40202

Research Facility, Louisville

41100

Research Facility, Modena

43606

Research Facility, Toledo

48202

Research Facility, Detroit

48236

Research Facility, Detroit

56017

Research Facility, Vannes

59100

Research Facility, Prato

60141

Research Facility, Hines

60422

Research Facility, Flossmoor

60528

Research Facility, Franfurt

67655

Research Facility, Kaiserslautern

71603

Research Facility, Pine Bluff

71654

Research Facility, McGehee

71901

Research Facility, Hot Springs

73116

Research Facility, Oklahoma City

76015

Research Facility, Arlington

77099

Research Facility, Houston

78215

Research Facility, San Antonio

80031

Research Facility, Westminster

80054

Research Facility, Amiens

85012

Research Facility, Phoenix

90033

Research Facility, Los Angeles

90048

Research Facility, Los Angeles

90073

Research Facility, Los Angeles

90602

Research Facility, Whittier

91205

Research Facility, Glendale

92505

Research Facility, Riverside

93065

Research Facility, Simi Valley

93309

Research Facility, Bakersfield

95991

Research Facility, Yuba City

700503

Research Facility, Iași

01107

Research Facility, Springfield

02904

Research Facility, Providence

06-400

Research Facility, Ciechanów

40-027

Research Facility, Katowice

95-200

Research Facility, Pabianice

87-800

Research Facility, Włocławek

014461

Research Facility, Bucharest

050098

Research Facility, Bucharest

03010

Research Facility, Alicante

08025

Research Facility, Barcelona

08902

Research Facility, Barcelona

08907

Research Facility, Barcelona

SM5 1AA

Research Facility, Carshalton

E1 1BB

Research Facility, London

SE5 9RS

Research Facility, London

SW17 0QT

Research Facility, London

SA6 6NL

Research Facility, Swansea

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Affymax

INDUSTRY