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

Amgen

Status and phase

Completed

Phase 3

Conditions

Chronic Kidney Disease

Anemia

Treatments

Drug: darbepoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00925587

2006-003173-27 (EudraCT Number)

20060163

Details and patient eligibility

About

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.

Enrollment

358 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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