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Epoetin alfa in Elderly Patients with Idiopathic Anemia of Aging

NCT00228995Phase 2

Key facts

Status: Terminated
Start: Jun 2004
Sponsor: Johnson & Johnson
Modality: Biologic, rProtein (Recombinant Protein)

Drugs: epoetin alfa
Conditions: idiopathic aplastic anemia

Overview

Phase 2, randomised, double-blind trial in idiopathic aplastic anemia comparing Epoetin alfa with Placebo (2 arms). Primary endpoint: Short Physical Performance Battery summary score. Started Jun 2004; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Epoetin alfa
Epoetin alfa 10,000 units SC weekly
Placebo
Placebo SC weekly

Who it enrols

Elderly patients (>=65) with idiopathic anemia of aging (Hb <= 11.0 g/dL), community dwelling, with some physical limitation (SPPB 4-10) and adequate cognition (MMSE >= 24).

Endpoints

Primary

Short Physical Performance Battery summary score

Secondary

Hemoglobin level
Functional Assessment of Cancer Therapy-Anemia score
Six-Minute Walk Test
Adverse Event incidence, Lab Tests, and Vitals
Cognitive function
Number and type of injuries from falls

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