Who is sponsoring NCT01624948?

NCT01624948 is sponsored by University of California, San Francisco.

What condition does NCT01624948 study?

NCT01624948 studies BK Virus Infection.

What drugs are being tested in NCT01624948?

Interventions: Everolimus, Mycophenolic acid dose reduction.

What is the status of NCT01624948?

NCT01624948 is currently COMPLETED.

Last reviewed 2016-07-01 · How we verify

Safety and Efficacy of Mycophenolic Acid Withdrawal With Conversion to Zortress (Everolimus) in Renal Transplant Recipients With BK Virus Infection

NCT01624948 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	COMPLETED
Enrolment	40
Start date	2012-09
Completion	2015-11

Conditions

BK Virus Infection

Interventions

Everolimus
Mycophenolic acid dose reduction

Primary outcomes

Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia — 3 months post-randomization
composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization

Countries

United States