Trials / Completed
CompletedNCT00111098
Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
A Multicenter, Single Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing In Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who have achieved and maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and their caregivers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Darbepoetin Alfa | QM administration for 28 weeks, adjusted as necessary to maintain Hb between 11.0 - 13.0 g/dL PFS concentrations: 20, 30, 40, 50, 60, 80, 100, 150, 200 and 300 mcg. |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2005-11-01
- Completion
- 2005-11-01
- First posted
- 2005-05-18
- Last updated
- 2008-08-08
Source: ClinicalTrials.gov record NCT00111098. Inclusion in this directory is not an endorsement.