Comparison Among Erythropoietin Stimulating Agents

PHASE4CompletedINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

June 30, 2013

Conditions
Anemia of End Stage Renal Disease
Interventions
DRUG

Epoetin alpha or beta (Epoetin group)

"Erythropoetin doses in that were adjusted according to the approved prescribing information, without additional restrictions.~Doses of erythropoetin were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. erythropoetin doses were increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.~The doses for all patients were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study."

DRUG

Darbepoetin alfa

"Subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. Doses of Darbepoetin alfa were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. Darbepoetin alfa doses and increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.~The doses were adjusted so that haemoglobin concentrations were remain within a target range of 11-12 g/dL during the study.~If a dose of Epoetin alpha/ beta does not equate exactly to a unit dose of Darbepoetin alfa at switching, then the nearest available unit dose of Darbepoetin alfa was used."

DRUG

Methoxy polyethylene glycol-epoetin beta

"Patients in that arm received Intravenous MIRCERA monthly. The initial dose was 120 mcg, 200 mcg or 360 mcg, for patients had previously received a weekly dose of Epoetin alpha/ beta of less than 8000 IU, between 8000 to16 000 IU or more than16000IU respectively. MIRCERA doses were adjusted according to the approved prescribing information, without additional restrictions.~Doses of MIRCERA were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. MIRCERA doses were increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.~The doses of MIRCERA were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study."

Trial Locations (1)

30550

Fahd Bin Jassem Dialysis Centre, Doha

Sponsors
All Listed Sponsors
lead

Hamad Medical Corporation

INDUSTRY