Conditions: Anemia Chronic Kidney Disease
Keywords: Quality of Life Chronic Kidney Disease Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 51
Healthy volunteers: no

Brief summary:
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks

Detailed description:
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.

Arms:
arm 1: Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months. arm 2: Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.

Interventions: intervention 1: Darbepoetin alfa intervention 2: Placebo
Intervention descriptions: intervention 1: Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion. intervention 2: Prefilled syringe placebo, to match active arm

Protocol document: