drugset / Trial / NCT02328963

Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

NCT02328963

Phase 4 Completed 186 enrolled University Hospital, Bordeaux Novartis · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.

Timeline

Start
2014-05-02
Primary completion
2018-10-10
Completion
2018-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule
Comparator mycophenolic acid Small molecule 720 mg