NCT00956293

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

6-month, Open-label, Randomized, Multicenter, Prospective, Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Basiliximab	On day 0, 2 hours prior to transplant and day 4 post-transplant, 20 mg x2 were given to all participants. Post randomization, 20mg at weeks 7 and 12 were given to the Everolimus group.
DRUG	Enteric Coated Mycophenolic Acid (MPA)	A loading dose regimen of 2880 mg/day during weeks 1 and 2 (pre-randomization) were given. During weeks 3 - 6 (pre-randomization), 2160 mg/day were given and during weeks 7 - 24, 1440 mg/day were given if tolerated. Dose reductions due to side effects were possible.
DRUG	RAD001	Upon randomization, 3 mg (od) on Day 1, and 3 mg (1.5 mg every 12 hours) on Day 2 was given. Afterwards, the dosage was based on blood trough level (5 - 10 ng/mL).
DRUG	Cyclosporin A (CsA)	Dosage was based according to blood level
DRUG	Corticosteroids	Dosage was administered according to local standards and administration was optional as per clinical need and the Investigators' discretion. Steroid withdrawal occurred after week 2 (pre-randomization).

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-08-11
• Last updated: 2014-06-06
• Results posted: 2014-05-12

Locations

9 sites across 1 country: Germany