A Multicenter, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
- Conditions
- MedDRA version: 7.0Level: PTClassification code 10049105Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
- Registration Number
- EUCTR2006-000074-79-DE
- Lead Sponsor
- Amgen Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
= 18 years of age
Receiving dialysis for = 3 months before enrollment
The mean of 2 screening Hb values taken at least 7 days apart must be = 11.0 g/dL and = 13.0 g/dL
The 2 screening Hb values must be = 11 g/dL and = 13 g/dL
Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment (defined as = 25% change in dose over the 6-week period immediately prior to enrollment and no change in frequency)
Adequate iron stores (serum ferritin > 100 µg/L)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Uncontrolled hypertension
Prior history (within 12 weeks before enrollment) of events including: acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack
Other hematological disorders
Upper or lower GI bleeding within the prior 6 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the proportion of subjects successfully achieving a mean Hemoglobin (Hb) = 11 g/dL during the evaluation period following extension from QW to Q2W darbepoetin alfa administration.;Secondary Objective: To determine Hb values over the duration of the study<br>To determine darbepoetin alfa doses over the duration of the study<br>To assess the safety of darbepoetin alfa administered Q2W<br>;Primary end point(s): Achievement of a mean Hb during the evaluation period > 11 g/dL.<br><br>
- Secondary Outcome Measures
Name Time Method