Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

PHASE3CompletedINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

December 31, 2009

Conditions
Chronic Renal FailureChronic Kidney DiseaseAnemia
Interventions
DRUG

peginesatide

Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).

DRUG

peginesatide

Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

DRUG

Darbepoetin alfa

Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Trial Locations (64)

1431

Research Facility, Sofia

1606

Research Facility, Sofia

2143

Research Facility, Kistarcsa

5000

Research Facility, Veliko Tarnovo

7900

Research Facility, Szigetvár

8230

Research Facility, Balatonfüred

9000

Research Facility, Varna

11355

Research Facility, Flushing

14021

Research Facility, Prague

14221

Research Facility, Williamsville

17109

Research Facility, Demmin

20852

Research Facility, Rockville

22030

Research Facility, Fairfax

23900

Research Facility, Lecco

26506

Research Facility, Morgantown

27100

Research Facility, Pavia

28801

Research Facility, Asheville

30060

Research Facility, Marietta

30114

Research Facility, Canton

31904

Research Facility, Columbus

33028

Research Facility, Pembroke Pines

33156

Research Facility, Pinecrest

33313

Research Facility, Lauderdale Lakes

39003

Research Facility, Tábor

43210

Research Facility, Columbus

46545

Research Facility, Mishawaka

48098

Research Facility, Troy

48202

Research Facility, Detroit

48236

Research Facility, Detroit

48504

Research Facility, Flint

49770

Research Facility, Petoskey

50010

Research Facility, Ames

54956

Research Facility, Neenah

60611

Research Facility, Chicago

63090

Research Facility, Washington

70506

Research Facility, Lafayette

70809

Research Facility, Baton Rouge

72703

Research Facility, Fayetteville

76015

Research Facility, Arlington

77004

Research Facility, Houston

78229

Research Facility, San Antonio

83605

Research Facility, Caldwell

83642

Research Facility, Meridian

85012

Research Facility, Phoenix

90022

Research Facility, Los Angeles

90603

Research Facility, Whittier

91344

Research Facility, Granada Hills

92123

Research Facility, San Diego

92708

Research Facility, Fountain Valley

92835

Research Facility, Fullerton

97701

Research Facility, Bend

98405

Research Facility, Tacoma

410469

Research Facility, Oradea

01107

Research Facility, Springfield

05401

Research Facility, Burlington

591 01

Research Facility, Zdar

15 540

Research Facility, Bialystok

80 952

Research Facility, Gdansk

40 027

Research Facility, Katowice

22 400

Research Facility, Zamość

00717-0634

Research Facility, Ponce

700 503

Research Facility, Iași

300 736

Research Facility, Timișoara

SE5 9RS

Research Facility, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Affymax

INDUSTRY