Phase 2 Study of Darbepoetin Alfa Extended Dosing
- Registration Number
- NCT00527215
- Lead Sponsor
- Amgen
- Brief Summary
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
- Greater than or equal to 18 years of age
- CRI with a creatinine clearance of greater than 15 but less than 40 mL/min
- Stable once every other week darbepoetin alfa SC for at least 6 weeks
- Hb values during screening / baseline of 10.0 - 12.0 g/dL
- Serum B12 and folate levels above the lower limit of normal and iron replete
Exclusion Criteria
- Receiving renal replacement therapy
- Uncontrolled hypertension
- Hyperparathyroidism
- Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
- Current malignancy
- Pregnant or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description darbepoetin alfa darbepoetin alfa -
- Primary Outcome Measures
Name Time Method To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks Study weeks 21 - 29
- Secondary Outcome Measures
Name Time Method To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks. Entire study