- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00121602
Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease
February 21, 2008 updated by: Amgen
Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
446
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Roller bottle
|
Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment.
Frequency either once a week or once every two weeks, frequency may not change for duration of study.
Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study.
Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.
|
Experimental: Serum free
|
Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment.
Frequency either once a week or once every two weeks, frequency may not change for duration of study.
Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study.
Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Hb level between the screening/baseline period and the evaluation period
Time Frame: 30 weeks
|
30 weeks
|
The ratio of weekly dosing requirements between baseline and the evaluation period
Time Frame: 28 weeks
|
28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline Hb over time
Time Frame: 29 weeks
|
29 weeks
|
Proportion of subjects maintaining mean Hb within target range during evaluation period
Time Frame: 7 weeks
|
7 weeks
|
Average darbepoetin alfa dose over evaluation period
Time Frame: 7 weeks
|
7 weeks
|
Change from baseline dose over time
Time Frame: 29 weeks
|
29 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
July 18, 2005
First Submitted That Met QC Criteria
July 18, 2005
First Posted (Estimate)
July 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 28, 2008
Last Update Submitted That Met QC Criteria
February 21, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20040104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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