Phase 2
N=157
A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.
Renal Failure , Chronic · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00337935 ↗Enrolled (actual)
157
Serious AEs
33.8%
Results posted
May 2013
Primary outcome: Primary: Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks) — 0.3; 0.9 g/dL — p=.0062
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epoetin Alfa (Drug); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks) |
0.3; 0.9 | .0062 sig |
| SECONDARY The Number of Patients Achieved a Hemoglobin Response. |
21; 97 | <0.001 sig |
| SECONDARY Time to Hemoglobin Response |
114; 41 | <0.0001 sig |
Summary
The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.
Eligibility Criteria
Inclusion Criteria
- Chronic Kidney Disease (CKD) Stage 3, 4, or 5 (not on dialysis), Glomerular Filtration Rate (GFR) [ 170 mm/Hg, or diastolic BP > 100 mm/Hg), or congestive heart failure (New York Heart Association (NYHA) Class IV)
- No known solid tumor malignancy, receiving chemotherapy for cancer or having major surgery within one month prior to screening or expected during study participation
- No history of receiving a transplanted organ, or scheduled to receive an organ transplant during the course of the study, with the exception of a corneal transplant.
Data sourced from ClinicalTrials.gov (NCT00337935). 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.