drugset / Trial / NCT02314312

Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors

NCT02314312

Phase 3 Unknown 48 enrolled Mahidol University
RandomizedParallel-groupOpen-labelTreatment

Summary

Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation

Timeline

Start
2012-01
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule
Background Cyclosporine Peptide
Background Prednisolone Other / unclassified

Indications

No indication recorded.