Trials / Completed
CompletedNCT00112008
Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis
A Multi-Center, Single-Arm Study Evaluating De Novo Once Every Two Week Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (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 are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | De Novo Administration of Darbepoetin Alfa | Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2005-03-01
- Completion
- 2005-03-01
- First posted
- 2005-05-30
- Last updated
- 2009-07-10
Source: ClinicalTrials.gov record NCT00112008. Inclusion in this directory is not an endorsement.