NCT02334488

Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Prospective Multicenter Randomized Openlabel Study to Evaluate the Benefit on Renal Function at 12months Post-transplantation of Immunosuppressive Treatment With Withdrawal of Calcineurin Inhibitor at 3months and Combining Mycophenolate Sodium-Everolimus Versus Tacrolimus-Everolimus, in Patients With de Novo Kidney Transplant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Everolimus	Active Comparator
DRUG	Tacrolimus	Active Comparator
DRUG	Mycophenolate sodium	Experimental Arm

Timeline

• Start date: 2014-12-11
• Primary completion: 2019-05-31
• Completion: 2020-07-03
• First posted: 2015-01-08
• Last updated: 2021-01-29

Locations

14 sites across 1 country: France