Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Anemia
Interventions
DRUG

Peginesatide

Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.

Trial Locations (10)

Unknown

Los Angeles

Sacramento

San Diego

Middlebury

Lauderdale Lakes

Shreveport

Dearborn

Columbus

Mineola

Arlington

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Affymax

INDUSTRY

lead

Takeda

INDUSTRY

NCT00752609 - Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa. | Biotech Hunter | Biotech Hunter