Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis

PHASE2CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
AnemiaChronic Kidney DiseaseChronic Renal Failure
Interventions
DRUG

peginesatide

Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.

DRUG

peginesatide

Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.

DRUG

peginesatide

Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.

DRUG

peginesatide

Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.

DRUG

peginesatide

Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.

DRUG

peginesatide

Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.

Trial Locations (15)

1527

Research Facility, Sofia

1606

Research Facility, Sofia

1709

Research Facility, Sofia

4003

Research Facility, Plovdiv

5000

Research Facility, Veliko Tarnovo

5800

Research Facility, Pleven

7002

Research Facility, Rousse

8000

Research Facility, Burgas

9010

Research Facility, Varna

300736

Research Facility, Timișoara

310017

Research Facility, Arad

600114

Research Facility, Bacau

700503

Research Facility, Iași

Unknown

Research Facility, Bucharest

SE5 9RS

Research Facility, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Affymax

INDUSTRY

NCT00434330 - Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis | Biotech Hunter | Biotech Hunter