Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

NCT00579046 | Withdrawn Phase 3 DMC

• 1 other identifier: P 061011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anemia; Chronic Obstructive Pulmonary Disease

Keywords

Anemia; Chronic obstructive Pulmonary Disease; Erythropoietin; 6-minute walk test

Outcome Measures

Primary Outcomes (1)

• Measure: 6-minute walk distance

  before treatment; at one month and two months of treatment

Secondary Outcomes (4)

• VO2 max

  before treatment; at one month and two months

• MRC Dyspnea score

  before treatment; at one month and two months

• St. George quality of life score

  before treatment and at two months of treatment

• Inflammation biological parameters

  before treatment and at two months of treatment

Study Arms (1)

1

EXPERIMENTAL

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfa DRUG

Dosage form: injection (to store between 2 and 8 °C). Dosage: various dosages are available (10, 15, 20, 30, 40, 50, 60, 80, 100, 150 or 300 µg/ml). Frequency: every week for 2 months: 8 injections

1

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Henri Mondor

Créteil, 94 000, France

Location

MeSH Terms

Conditions

Anemia; Pulmonary Disease, Chronic Obstructive

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Laurent Savale, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 21, 2007
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

FR (1)