Sirolimus vs Mycophenolate With Tacrolimus in Simultaneous Pancreas and Kidney Transplantation

Phase 4 Completed 238 enrolled Institute for Clinical and Experimental Medicine

RandomizedParallel-groupOpen-labelTreatment

Summary

This is prospective randomized open single center clinical study to compare effect of sirolimus vs mycophenolate tacrolimus based protocol on pancreas and kidney graft survival in simultaneous pancreas and kidney recipients.

Timeline

Start: 2004-01-01
Primary completion: 2019-01-01
Completion: 2019-01-01

Outcome

Missed primary endpoint

paper Noncensored pancreas survival at 5 years was 76.4 and 71.6% for sirolimus and MMF groups, respectively (P > .05). PMID 31561278 ↗

Publications

Girman P, Lipar K, Kocik M, Voska L, Koznarova R, Marada T, Lanska V, Saudek F. Sirolimus vs mycophenolate mofetil (MMF) in primary combined pancreas and kidney transplantation. Results of a long-term prospective randomized study. Am J Transplant. 2020 Mar;20(3):779-787. doi: 10.1111/ajt.15622. Epub 2019 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Mycophenolate Mofetil	Small molecule	1 g	—
Subject	Sirolimus	Small molecule	5 mg	Oral