Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

PHASE2CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
AnemiaChronic Renal FailureChronic Kidney Disease
Interventions
DRUG

peginesatide

Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose 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 intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

DRUG

Epoetin Alfa

Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Trial Locations (11)

Unknown

Research Facility, Irkutsk

Research Facility, Krasnodar

Research Facility, Krasnoyarsk

Research Facility, Moscow

Research Facility, Nizhny Novgorod

Research Facility, Omsk

Research Facility, Petrozavodsk

Research Facility, Saint Petersburg

Research Facility, Saratov

Research Facility, Tver'

Research Facility, Volzhsk

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Affymax

INDUSTRY

NCT00680043 - Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA | Biotech Hunter | Biotech Hunter