Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

• Status: Withdrawn
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the impact of erythropoietin treatment of anemia on exercise capacity of patients with chronic obstructive pulmonary disease (COPD).

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• Male and female aged 40-75 years

• Diagnosis of a moderate to very severe COPD (stage II, III or IV according to GOLD criteria)

• A ratio of post-bronchodilator FEV1 to forced vital capacity (FVC) < 70%

• A FEV1 < 80% of the predicted value

• Hemoglobin level less than 12 g/dL

• Peak VO2 less than 80% of predict value and 6-min walk test distance less than 500 meters

Exclusion Criteria:

• Hemorrhagic anemia

• Iron deficiency anemia (ferritin < 30 ng/ml)

• Folate and Vitamin B12 deficiency anemia

• Myelodysplastic Syndrome

• Chronic disease associated with anemia: renal insufficiency, inflammatory disease, neoplastic disease, left ventricular insufficiency (ejection fraction < 40%)

• Chronic disease likely to interfere with dyspnea or exercise testing (cardiac insufficiency, neurologic disease, claudication)

• Acute exacerbation of COPD within the last 4 weeks

• History of thromboembolic disease

• Contraindications for cardiopulmonary exercise testing

• Contraindications for darbepoetin alfa treatment: uncontrolled arterial hypertension or hypersensitivity reaction to darbepoetin alfa

• Pregnancy or breast-feeding (women of reproductive potential should use adequate birth control measures during the whole duration of study treatment)