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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

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