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Study Complete
Sponsor ID
20040104

Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients with Chronic Kidney Disease

Sponsor ID
20040104
Clinicaltrials.gov ID
NCT00121602
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with chronic kidney disease (CKD) receiving hemodialysis.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
446
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in Hb level between the screening/baseline period and the evaluation period

Timeframe: 30 weeks

The ratio of weekly dosing requirements between baseline and the evaluation period

Timeframe: 28 weeks

Secondary Outcome Measures

Change from baseline Hb over time

Timeframe: 29 weeks

Proportion of subjects maintaining mean Hb within target range during evaluation period

Timeframe: 7 weeks

Average darbepoetin alfa dose over evaluation period

Timeframe: 7 weeks

Change from baseline dose over time

Timeframe: 29 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Mar 2005 - Oct 2005
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before enrollment - No prior exposure to EPREX® or NeoRecorman® - Baseline hemoglobin (Hb) between 10 and 13 g/dL - On stable weekly or once every other week intravenous (IV) or subcutaneous (SC) darbepoetin therapy for at least 6 weeks prior to screening (stable is defined as less than 25% change in weekly dose and no change in frequency) - Adequate iron stores (serum ferritin equal to or greater than 100 mg/L) - Before any study-specific procedure, the appropriate written informed consent must be obtained
    Exclusion Criteria:
    - Scheduled to receive a kidney transplant - Uncontrolled hypertension, defined as a pre-dialysis systolic blood pressure (BP) greater than 180 and/or diastolic BP of greater than 110 - Acute myocardial ischemia; hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment - Parathyroid hormone (PTH) level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - Known positive HIV antibody or positive hepatitis B surface antigen - Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia) - Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - Pregnant or breast-feeding women. All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. - Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Subject has known sensitivity to any of the products to be administered during dosing.