drugset / Trial / NCT01878786

A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys

NCT01878786

Phase 2/3 Terminated 25 enrolled Matthew Cooper
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this pilot study is to evaluate concentration-controlled everolimus with low dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard dose tacrolimus in de novo renal transplant recipients of ECD/DCD kidneys. Given tacrolimus and MMF/MPA is a widely prescribed immunosuppressive regimen in the United States, comparisons of tacrolimus and MMF/MPA regimens to investigational therapies and treatment regimens are needed. Also, considering the fact that ECD/DCD is a fast growing fraction of donors, evaluation of various regimens' effects on rather delicate ECD/DCD kidneys is necessary.

Timeline

Start
2013-06
Primary completion
2017-11
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule
Subject Mycophenolate mofetil (MMF/MPA) Unknown
Subject Tacrolimus Small molecule

Indications

No indication recorded.