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

PHASE3CompletedINTERVENTIONAL
Enrollment

803

Participants

Timeline

Start Date

September 30, 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 injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (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

Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa 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 (89)

10128

Research Facility, New York

10461

Research Facility, The Bronx

10467

Research Facility, The Bronx

10710

Research Facility, Yonkers

11212

Research Facility, Brooklyn

14221

Research Facility, Williamsville

15224

Research Facility, Pittsburgh

18103

Research Facility, Allentown

19106

Research Facility, Philadelphia

19144

Research Facility, Philadelphia

20817

Research Facility, Bethesda

20852

Research Facility, Rockville

22030

Research Facility, Fairfax

22304

Research Facility, Alexandria

23116

Research Facility, Mechanicsville

23320

Research Facility, Chesapeake

23507

Research Facilities (2), Norfolk

26506

Research Facility, Morgantown

27609

Research Facility, Raleigh

27704

Research Facility, Durham

29150

Research Facility, Sumter

29605

Research Facilities (2), Greenville

30030

Research Facility, Decatur

30060

Research Facility, Marietta

30901

Research Facility, Augusta

30912

Research Facility, Augusta

32804

Research Facility, Orlando

32806

Research Facility, Orlando

33028

Research Facility, Pembroke Pines

34471

Research Facility, Ocala

34667

Research Facility, Hudson

37205

Research Facility, Nashville

37923

Research Facility, Knoxville

38024

Research Facility, Dyersburg

38801

Research Facility, Tupelo

39705

Research Facility, Columbus

40513

Research Facility, Lexington

43210

Research Facility, Columbus

44718

Research Facility, Canton

45267

Research Facility, Cincinnati

47714

Research Facility, Evansville

48195

Research Facility, Dearborn

49007

Research Facility, Kalamazoo

54904

Research Facility, Oshkosh

54956

Research Facility, Appleton

60031

Research Facility, Gurnee

60661

Research Facility, Chicago

60805

Research Facility, Evergreen Park

61603

Research Facility, Peoria

63110

Research Facility, St Louis

67214

Research Facility, Wichita

70112

Research Facility, New Orleans

70506

Research Facility, Lafayette

70809

Research Facility, Baton Rouge

71101

Research Facility, Shreveport

72450

Research Facility, Paragould

75050

Research Facility, Grand Prairie

75701

Research Facility, Tyler

76011

Research Facility, Arlington

76105

Research Facility, Fort Worth

76106

Research Facility, Fort Worth

76133

Research Facility, Fort Worth

77054

Research Facilities (2), Houston

77091

Research Facility, Houston

78205

Research Facility, San Antonio

78229

Research Facility, San Antonio

78503

Research Facility, McAllen

80230

Research Facility, Denver

83706

Research Facility, Boise

89106

Research Facility, Las Vegas

90022

Research Facility, Los Angeles

90033

Research Facility, Los Angeles

90095

Research Facility, Los Angeles

90262

Research Facility, Lynwood

90603

Research Facility, Whittier

90720

Research Facility, Los Alamitos

90723

Research Facility, Paramount

91344

Research Facility, Granada Hills

91754

Research Facility, Monterey Park

91773

Research Facility, San Dimas

92123

Research Facilities (2), San Diego

94041

Research Facility, Mountain View

94533

Research Facility, Fairfield

96817

Research Facility, Honolulu

97471

Research Facility, Roseburg

06762

Research Facility, Middlebury

02720

Research Facility, Fall River

01605

Research Facility, Worcester

07724

Research Facility, Eatontown

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Affymax

INDUSTRY