Trials / Completed
CompletedNCT00096915
Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
A Multicenter, Single-Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 110 (actual)
- 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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2005-11-01
- Completion
- 2005-11-01
- First posted
- 2004-11-18
- Last updated
- 2009-05-22
Source: ClinicalTrials.gov record NCT00096915. Inclusion in this directory is not an endorsement.