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

PHASE3CompletedINTERVENTIONAL
Enrollment

490

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

February 28, 2010

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

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

Trial Locations (72)

11021

Research Facility, Great Neck

11501

Research Facility, Mineola

13903

Research Facility, Binghamton

15905

Research Facility, Johnstown

16507

Research Facility, Erie

18103

Research Facility, Allentown

20037

Research Facility, Washington D.C.

20814

Research Facility, Bethesda

24153

Research Facility, Salem

24701

Research Facility, Bluefield

28208

Research Facility, Charlotte

29118

Research Facility, Orangeburg

29732

Research Facility, Rock Hill

30901

Research Facility, Augusta

32117

Research Facility, Holly Hill

32804

Research Facility, Orlando

33173

Research Facility, Miami

33614

Research Facility, Tampa

34471

Research Facility, Ocala

34667

Research Facility, Hudson

36106

Research Facility, Montgomery

37043

Research Facility, Clarksville

37205

Research Facility, Nashville

37923

Research Facility, Knoxville

39705

Research Facility, Columbus

47714

Research Facility, Evansville

47904

Research Facility, Lafayette

48640

Research Facility, Midland

60141

Research Facility, Hines

60616

Research Facility, Chicago

60805

Research Facility, Evergreen Park

64128

Research Facility, Kansas City

67214

Research Facility, Wichita

71101

Research Facility, Shreveport

71901

Research Facility, Hot Springs

73116

Research Facility, Oklahoma City

75110

Research Facility, Corsicana

77030

Research Facility, Houston

77099

Research Facility, Houston

78215

Research Facility, San Antonio

78229

Research Facility, San Antonio

78404

Research Facility, Corpus Christi

78539

Research Facility, Edinburg

78705

Research Facility, Austin

80031

Research Facility, Thornton

85306

Research Facility, Tempe

90095

Research Facility, Los Angeles

90603

Research Facility, Whittier

90606

Research Facility, Whittier

90723

Research Facility, Paramount

91106

Research Facility, Pasadena

91204

Research Facility, Glendale

91773

Research Facility, San Dimas

91910

Research Facility, Chula Vista

92505

Research Facility, Riverside

92646

Research Facility, Huntington Beach

92868

Research Facility, Orange

93309

Research Facility, Bakersfield

95991

Research Facility, Yuba City

96817

Research Facility, Honolulu

97210

Research Facility, Portland

97701

Research Facility, Bend

94305-6203

Research Facility, Stanford

02720

Research Facility, Fall River

01608

Research Facility, Worcester

08225

Research Facility, Northfield

08755

Research Facility, Toms River

02904

Research Facility, Providence

00725

Research Facility, Caguas

00716

Research Facility, Ponce

00909

Research Facility, San Juan

00918

Research Facility, San Juan

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Affymax

INDUSTRY

NCT00598273 - Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis | Biotech Hunter | Biotech Hunter