Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.

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

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• ≥ 18 years of age

• Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)

• Two consecutive screening Hb values taken at least 7 days apart must each be <10.0 g/dL

• TSAT ≥ 15%

Exclusion Criteria:

• Upper or lower GI bleeding within 6 months before enrolment

• ESA use within 12 weeks before enrolment

• Uncontrolled hypertension

• Systemic haematologic disorders

• Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism.

• Grand mal seizure within 6 months prior to enrolment

• Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment.

• Red blood cell transfusion within 12 weeks prior to enrolment

• Androgen therapy within 8 weeks prior to enrolment

• Pregnancy or breast feeding, or inadequate contraception

• Currently receiving immunosuppressive therapy