Trials / Completed
CompletedNCT00369772
STAAR-1 Clinical Study
A Multicenter Study Evaluating Once Every Other Week Subcutaneous Administration of Aranesp (Darbepoetin Alfa) in Subjects With Anemia of Chronic Renal Insufficiency (CRI)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2,000 (planned)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the effect of Aranesp on the hemoglobin of CRI subjects who are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy
Detailed description
To assess the effect of Aranesp on the hemoglobin of CRI subjectswho are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy and to assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment. To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp™ compared to previous rHuEPO therapy. To characterize iron treatment in subjects with CRI. To assess the safety profile of Aranesp™ therapy in subjects with CRI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | darbepoetin alfa |
Timeline
- Start date
- 2002-02-01
- Completion
- 2004-05-01
- First posted
- 2006-08-29
- Last updated
- 2009-10-16
Source: ClinicalTrials.gov record NCT00369772. Inclusion in this directory is not an endorsement.