Phase 3
Completed N=430
PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
Source: ClinicalTrials.gov NCT00440466 ↗Enrolled (actual)
430
Serious AEs
25.1%
Results posted
Apr 2011
Primary outcomePrimary: Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment — -0.02; -0.10; -0.19 g/dL
Summary
The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment |
-0.02; -0.10; -0.19 | — |
| SECONDARY Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL) |
0.87; 0.88; 0.83 | — |
Eligibility Criteria
Inclusion Criteria
- Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) >=15 mL/min per 1.73 m2 and <60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
- Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization
- History of increase in hemoglobin after the initial dose
- Stable dose of epoetin alfa given once-weekly before randomization.
Exclusion Criteria
- Uncontrolled hypertension
- Iron deficiency
- iron overload
- severe congestive heart failure
- Active infection
- Recent heart attack, Stroke or blood clot.
Data sourced from ClinicalTrials.gov (NCT00440466). 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.