Conditions: Kidney Disease Diabetes Mellitus Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4038
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.

Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo intervention 2: darbepoetin alfa
Intervention descriptions: intervention 1: Volume and dose frequency changes resembling dosing in the active treatment group intervention 2: Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL

Protocol document: