Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant

Summary

This is a 12-month single center, randomized, open-label, single center study designed to compare the safety and efficacy of everolimus and very low dose tacrolimus versus enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant recipients. The purpose of this study is to compare safety and efficacy of two immunosuppressive regimens based on low tacrolimus exposure combined to everolimus or to enteric-coated mycophenolate sodium (EC-MPS) in de novo kidney transplant recipients.

Timeline

Start

2012-12

Primary completion

2014-07

Completion

2017-07

Publications

• de Sandes-Freitas TV, Pinheiro PMA, Sales MLMBO, Girao CM, Campos EF, Esmeraldo RM. The impact of everolimus in reducing cytomegalovirus events in kidney transplant recipients on steroid-avoidance strategy: 3-year follow-up of a randomized clinical trial. Transpl Int. 2018 Dec;31(12):1345-1356. doi: 10.1111/tri.13313. Epub 2018 Jul 31.

Drugs

Indications