Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-09-30

Brief Summary

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The purpose of this study is to compare once a week and once every other week darbepoetin alfa on the change in hemoglobin levels between the screening/baseline period and the evaluation period (weeks 25-30). This study will also assess the change in mean hemoglobin over 4 week intervals, instability of hemoglobin concentrations, darbepoetin alfa dosing requirements and red blood cell transfusions.

Detailed Description

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Conditions

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Anemia

Keywords

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Hemodialysis darbepoetin alfa Clinical Trial Amgen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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darbepoetin alfa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - -Receiving hemodialysis for at least 6 months before screening - -Clinically stable as judged by the investigator - Stable IV rHuEPO therapy administered 1, 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than or equal to 25% change \[up or down\] in weekly dose and no change in frequency over 8 weeks) - Adequate iron stores (serum ferritin greater than or equal to 100μg/L) during the screening period - Available for follow up assessments - Before any study specific procedure is carried out, the subject, or his/her legally acceptable representative must give informed consent for participation in the study Exclusion Criteria: - -Treatment for grand mal epilepsy in the last 6 months - Congestive heart failure (New York Heart Association \[NYHA\] class III or IV)- - Uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement greater than or equal to 110mmHg during the screening period - Clinical evidence of current uncontrolled hyperparathyroidism (e.g., serum parathyroid hormone greater than 1500pg/mL) within the past 12 months - Major surgery within 3 months before screening (excludes vascular access surgery) - Previously diagnosed HIV or chronic hepatitis B infection - Clinical evidence of current malignancy excluding basal cell or squamous cell carcinoma of the skin - Systemic hematological disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia - Alanine transaminase (ALT) and aspartate transaminase (AST) greater than 2 times the upper limit of the normal range - RBC transfusion(s) within 12 weeks before screening or during the screening/baseline period, or active bleeding - Clinical evidence of current systemic infections - Androgen therapy within 12 weeks before screening - No prior treatment with darbepoetin alfa - Currently enrolled in, or has not yet completed a period of at least 30 days since ending, other investigational device or drug trial(s). Subjects receiving other investigational agent(s) may only enter the study after discussion and agreement with Amgen - Pregnancy (women of child-bearing potential must be using adequate contraception) - Breast feeding - Psychiatric, addictive, or other disorder that compromises ability to give truly informed consent or is likely to alter compliance - Anticipating or scheduled for a living-related kidney transplant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Other Identifiers

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20010219

Identifier Type: -

Identifier Source: org_study_id