Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

Phase 4 Terminated 207 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.

Timeline

Start: 2009-07
Primary completion: 2013-03
Completion: 2013-03

Publications

Brakemeier S, Arns W, Lehner F, Witzke O, Vonend O, Sommerer C, Muhlfeld A, Rath T, Schuhmann R, Zukunft B, Kroeger I, Porstner M, Budde K. Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: Results of a prospective randomized multicenter study (SENATOR). PLoS One. 2019 Sep 19;14(9):e0222730. doi: 10.1371/journal.pone.0222730. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Basiliximab	Monoclonal antibody	20 mg	—
Subject	Cyclosporine	Peptide	—	—
Subject	Everolimus	Small molecule	1.5 mg	—
Background	mycophenolic acid	Small molecule	1440 mg	—

Indications

No indication recorded.