Trial intelligence / Profile preview

Aranesp in Anemia of Chronic Renal Insufficiency

NCT00369733Phase 4

Key facts

Status: Completed
Start: May 2002
Primary completion: Mar 2004
Sponsor: Amgen
Modality: Erythropoietins, Colony Stimulating Factors

Drugs: darbepoetin alfa
Conditions: anemia of chronic kidney disease (CKD-A)

Overview

Phase 4, open-label, single-arm trial of darbepoetin alfa in anemia of chronic kidney disease (CKD-A), sponsored by Amgen. Primary endpoint: Mean hemoglobin during the evaluation period at 52 weeks. Started May 2002; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Single arm
Aranesp administered every other week for 52 weeks

Who it enrols

Pre-dialysis patients with Chronic Renal Insufficiency (CRI) and anemia (Hgb < 11 g/dL if naive), with adequate iron stores (TSAT >= 20%). Excludes patients on dialysis, with uncontrolled hypertension, severe hyperparathyroidism, or active infection.

Endpoints

Primary

Mean hemoglobin during the evaluation period52 weeks

Secondary

Change in hemoglobin throughout the study52 weeks
Health-related quality of life scores52 weeks
Health-related resource utilization52 weeks
Patient satisfaction scores12 weeks
Iron requirement52 weeks

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