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

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

Outcome

Missed primary endpoint

Stopped: “The study was terminated because the required sample size of 240-260 de novo senior renal transplant patients was not achieved within a reasonable time.”

paper At month 6, eGFR was comparable: 36.5±10.8ml/min with everolimus versus 42.0±13.0ml/min in the control group (p = 0.784). PMID 31536556 ↗

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	Cyclosporin A	Unknown	—	—
Subject	Everolimus	Small molecule	1.5 mg	—
Background	mycophenolic acid	Small molecule	1440 mg	—

Indications

No indication recorded.