Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

Phase 4 Completed 385 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.

Timeline

Start: 2000-04
Primary completion: —
Completion: 2002-06

Outcome

Mixed primary results

paper BCAR rates at 12 months were not significantly different: 11.2% for rCsA patients and 16.2% for sCsA patients. PMID 24266855 ↗

paper Mean serum creatinine (±SEM) was significantly lower (1.75 ± 0.10 vs. 1.97 ± 0.07 mg/dl, P < 0.001) PMID 24266855 ↗

paper The primary end points were the rate of biopsy-confirmed acute rejection (BCAR) and renal function, as measured by serum creatinine. PMID 24266855 ↗

Publications

Muhlbacher F, Neumayer HH, del Castillo D, Stefoni S, Zygmunt AJ, Budde K; European Rapamune Cyclosporine Minimization Study Group. The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids: results from an open-label comparative study. Transpl Int. 2014 Feb;27(2):176-86. doi: 10.1111/tri.12228. Epub 2013 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	—	—
Background	Sirolimus	Small molecule	—	—

Indications

No indication recorded.