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NCT01624948 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients
A Phase 4 study of BK Virus Infection, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01624948: Completed Phase 4 study of BK Virus Infection, sponsored by University of California, San Francisco.
NCT01624948 is a Phase 4 study of BK Virus Infection that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 74-participant average among 6 other BK Virus Infection trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624948, a Phase 4 study of BK Virus Infection, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Mycophenolic acid dose reduction
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-11 |
| Phase | Phase 4 |
What the finished NCT01624948 record still lists
NCT01624948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 74-participant average among 6 other BK Virus Infection trials with a reported enrollment target (46% lower).
The record links to 1 condition, with BK Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.
NCT01624948 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01624948 about?
NCT01624948 is a clinical study titled "Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients". 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 infe...
What is the current status of trial NCT01624948?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2012-09. Estimated completion is 2015-11.
What conditions does trial NCT01624948 study?
This clinical trial studies the following conditions: BK Virus Infection.
What interventions are being tested in trial NCT01624948?
The interventions under investigation include: Everolimus (DRUG), Mycophenolic acid dose reduction (DRUG).
Who is sponsoring clinical trial NCT01624948?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01624948 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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