Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
May 21, 2009 updated by: Amgen
A Multicenter, Single-Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis.
Anemic patients on hemo and peritoneal dialysis who have achieved and maintained target hemoglobin (Hb) on every other week (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
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 chronic kidney disease (CKD) and receiving dialysis for > 3 months before enrollment
- Clinically stable, in the judgment of the investigator
- Mean Hb > 11.0 g/dL (110 g/L) to < 13.0 g/dL (130 g/L)
- Transferrin saturation (Tsat) > 19.5%
- Serum vitamin B12 and folate levels above the lower limit of the normal range
- Receiving stable Q2W IV or SC doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period
Exclusion Criteria:
- Scheduled to receive a kidney transplant
- Diastolic blood pressure greater than 110 mm Hg or systolic BP greater than 180 mm Hg during screening
- Acute myocardial ischemia
- Hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack within 12 weeks before enrollment
- Parathyroid hormone (PTH) level greater than 1500 pg/mL (158.0 pmol/L)
- 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
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: darbepoetin alfa
|
QM administration for 32 weeks, allowable doses: 15, 20, 30, 40, 50, 60, 80, 100, 150, 200, 300, 400, 500, 600 and 800 mcg |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL and less than or equal to 13.0 g/dL during the evaluation phase
Time Frame: entire study
|
entire study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hb values over the duration of the study
Time Frame: entire study
|
entire study
|
|
Darbepoetin alfa doses over the duration of the study
Time Frame: entire study
|
entire study
|
|
Frequency and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure
Time Frame: entire study
|
entire study
|
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
October 1, 2004
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
November 17, 2004
First Submitted That Met QC Criteria
November 17, 2004
First Posted (Estimate)
November 18, 2004
Study Record Updates
Last Update Posted (Estimate)
May 22, 2009
Last Update Submitted That Met QC Criteria
May 21, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20040202
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.