Phase 3
Completed N=373
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease
Source: ClinicalTrials.gov NCT00440557 ↗Enrolled (actual)
373
Serious AEs
31.9%
Results posted
Feb 2010
Primary outcomePrimary: Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22 — 1.81; 1.59; 1.27 g/dL
Summary
The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22 |
1.81; 1.59; 1.27 | — |
| SECONDARY Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9 |
116; 108; 106 | — |
Eligibility Criteria
Inclusion Criteria
- Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
- Require support of an erythropoietin receptor agonist
Exclusion Criteria
- Uncontrolled hypertension
- Serum ferritin level less than 50 ng/mL
- Serum iron overload
- Severe congestive heart failure
- Active infection
Data sourced from ClinicalTrials.gov (NCT00440557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.