STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients

A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the Short-Form 36 (SF-36) Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.

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

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.

Inclusion Criteria:

• Stage 3-5 CKD not on dialysis
• Patients ≥ 70 years of age
• Haemoglobin < 110g/L at screening
• Transferrin saturation ≥ 15% at screening

Exclusion Criteria:

• Clinical history of type 2 diabetes mellitus
• Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
• Uncontrolled hypertension on two separate measurements during screening
• Use of any erythropoietic protein within 12 weeks of screening