Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients

Summary

This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection. The study will also determine if immune monitoring tests can detect an association between BK virus infection and transplant rejection episodes, based on the specific BKV infection treatment regimen. The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and tacrolimus + prednisone in patients who have undergone renal transplantation and have active BKV infections.

Timeline

Start

2012-09

Primary completion

2015-02

Completion

2015-11

Outcome

Missed primary endpoint

registry Everolimus+Tacrolimus/Prednisone vs Standard of Care: 50% Reduction of MPA; p = 0.53; Fisher Exact NCT01624948 ↗

Publications

• Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

Drugs

Indications