A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.

Phase 3 Completed 172 enrolled Janssen-Ortho Inc., Canada

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.

Timeline

Start: 1997-12
Primary completion: —
Completion: 2003-08

Outcome

Missed primary endpoint

paper There was no statistically significant difference between groups for the primary outcome of mean change in LV mass index (LVMI) from baseline to 24 months PMID 16253719 ↗

paper Absolute mean difference between groups was 4.85 g/m2 (95% confidence interval, -4.0 to 13.7; P = 0.28). PMID 16253719 ↗

Publications

Results Levin A, Djurdjev O, Thompson C, Barrett B, Ethier J, Carlisle E, Barre P, Magner P, Muirhead N, Tobe S, Tam P, Wadgymar JA, Kappel J, Holland D, Pichette V, Shoker A, Soltys G, Verrelli M, Singer J. Canadian randomized trial of hemoglobin maintenance to prevent or delay left ventricular mass growth in patients with CKD. Am J Kidney Dis. 2005 Nov;46(5):799-811. doi: 10.1053/j.ajkd.2005.08.007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	2000 iu	Subcutaneous
Subject	epoetin alfa	Protein / enzyme biologic	3000 iu	Subcutaneous