Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients

Phase 4 Completed 350 enrolled Asan Medical Center Samsung Medical Center · collab Seoul National University Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects Primary endpoints: 1. estimated GFR (MDRD equation) 12 months after randomization 2. estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)

Timeline

Start: 2010-04-01
Primary completion: 2016-10-30
Completion: 2016-11-30

Outcome

Mixed primary results

paper The primary endpoint was better in the study group in terms of change in eGFR (P<0.001). PMID 29891834 ↗

paper the difference did not reach statistical significance (P=0.07). PMID 29891834 ↗

Publications

Park S, Kim YS, Lee J, Huh W, Yang CW, Kim YL, Kim YH, Kim JK, Oh CK, Park SK. Reduced Tacrolimus Trough Level Is Reflected by Estimated Glomerular Filtration Rate (eGFR) Changes in Stable Renal Transplantation Recipients: Results of the OPTIMUM Phase 3 Randomized Controlled Study. Ann Transplant. 2018 Jun 12;23:401-411. doi: 10.12659/AOT.909036.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Sodium	Unknown	180 mg	Oral
Subject	Mycophenolate Sodium	Unknown	360 mg	Oral
Subject	Mycophenolate Sodium	Unknown	540 mg	Oral
Subject	Mycophenolate Sodium	Unknown	720 mg	Oral
Subject	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.