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.

Phase 2 Completed 157 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho Biotech Clinical Affairs, L.L.C. · collab

RandomizedFactorialOpen-labelTreatment

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.

Timeline

Start: 2006-07
Primary completion: 2009-07
Completion: 2009-07

Outcome

Met primary endpoint

registry MEAN Standard of Care: 0.3 (Standard Deviation 1.3) g/dL MEAN PROCRIT (Epoetin Alfa): 0.9 (Standard Deviation 1.0) g/dL NCT00337935 ↗

registry Standard of Care vs PROCRIT (Epoetin Alfa); p = .0062; Mean Difference (Net) 0.6 (95% CI 0.2 to 0.9) NCT00337935 ↗

Publications

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	20000 iu	Subcutaneous