Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

Phase 4 Completed 158 enrolled Yonsei University

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.

Timeline

Start: 2012-09
Primary completion: 2016-01
Completion: 2016-01

Outcome

Met primary endpoint

paper CONCLUSION: Low-dose SRL with ER-TAC was not inferior to MMF with ER-TAC with respect to efficacy and safety. PMID 28810721 ↗

Publications

Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Mofetil	Small molecule	1000 mg	Oral
Subject	Sirolimus	Small molecule	2 mg/kg	Oral
Background	Tacrolimus	Small molecule	0.1 mg/kg	Oral
Background	Tacrolimus	Small molecule	0.2 mg/kg	Oral

Indications

No indication recorded.