A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

Summary

This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.

Timeline

Start

2005-05

Primary completion

2006-07

Completion

2006-07

Publications

• Busque S, Leventhal J, Brennan DC, Steinberg S, Klintmalm G, Shah T, Mulgaonkar S, Bromberg JS, Vincenti F, Hariharan S, Slakey D, Peddi VR, Fisher RA, Lawendy N, Wang C, Chan G. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009 Aug;9(8):1936-45. doi: 10.1111/j.1600-6143.2009.02720.x.

Drugs

Indications

No indication recorded.