A Study of Four Dosing Regimens of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease. Protocol Addendum: Extension Study of Maintenance Therapy of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease.

Summary

The primary objective of this study is to compare the change in hemoglobin (Hb) from study start to the end of the study between the every 2 week and the every 4 week dosing regimens in patients with anemia of chronic kidney disease (CKD) initiated on PROCRIT (epoetin alfa). Protocol Addendum: The primary objective of the open-label extension portion of this study is to evaluate if epoetin alfa 40,000 Units given under the skin every six weeks, can maintain hemoglobin within the range of 11-12 g/dL in patients with anemia of CKD.

Timeline

Start

2005-09

Primary completion

—

Completion

2007-02

Outcome

Met primary endpoint

paper was not inferior to the 20,000 IU Q2W group (1.11 g/dl) with the lower limit of 95% CI, -0.21 g/dl. PMID 18400964 ↗

Publications

• Spinowitz B, Germain M, Benz R, Wolfson M, McGowan T, Tang KL, Kamin M; Epoetin Alfa Extended Dosing Study Group. A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease. Clin J Am Soc Nephrol. 2008 Jul;3(4):1015-21. doi: 10.2215/CJN.05681207. Epub 2008 Apr 9.

Drugs

Indications