24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

Phase 4 Completed 71 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients

Timeline

Start: 2010-08
Primary completion: 2014-03
Completion: 2014-03

Outcome

Missed primary endpoint

paper Conversion from TAC to EVR did not further reduce LVMi after 24 months PMID 27648523 ↗

Publications

Cruzado JM, Pascual J, Sanchez-Fructuoso A, Seron D, Diaz JM, Rengel M, Oppenheimer F, Hernandez D, Paravisini A, Saval N, Morales JM; Evita Study Group. Controlled randomized study comparing the cardiovascular profile of everolimus with tacrolimus in renal transplantation. Transpl Int. 2016 Dec;29(12):1317-1328. doi: 10.1111/tri.12862. Epub 2016 Oct 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	2 mg	—
Subject	Tacrolimus	Small molecule	—	—
Background	mycophenolic acid	Small molecule	—	—

Indications

No indication recorded.