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NCT01649609 · ClinicalTrials.gov registry record · NA
Using mTOR Inhibitors in the Prevention of BK Nephropathy
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01649609: Completed NA study, sponsored by Columbia University.
NCT01649609 is a NA study that has completed, run by Columbia University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01649609, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
BK virus infections after kidney transplant are increasing and can result in damage to the transplanted kidney. Currently, the universally accepted treatment is to decrease the strength of the antirejection medications but it is unclear what medications should be lowered and to what extent. The investigators propose to perform a study with patients who have BK virus detected in their blood during routine screening that appears to be increasing. The investigators will use two different strategies that involve different combinations of standard anti-rejection medications at lower dosages. Patients will be assigned to one of the two groups in a random manner across the two hospitals participating in the study. Patients will be followed for at least a year to determine if one strategy was more effective than the other in preventing an increase in the number of viruses in the blood stream and whether either one was more effective in reducing the negative impact of the infection on the functioning of the transplanted kidney.
Primary Outcome
A Viral load of \<600 copies/mL for at least 3 months indicates sustained clearance of BK viremia, confirmed by blood test
Interventions
- DRUG Sirolimus
- DRUG Tacrolimus
- DRUG Mycophenolate acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT01649609 record still lists
NCT01649609 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT01649609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01649609 about?
NCT01649609 is a clinical study titled "Using mTOR Inhibitors in the Prevention of BK Nephropathy". BK virus infections after kidney transplant are increasing and can result in damage to the transplanted kidney. Currently, the universally accepted treatment is to decrease the strength of the antirejection medications but it is unclear what medications should be lowered and to what extent. The inve...
What is the current status of trial NCT01649609?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2012-03. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01649609?
The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Mycophenolate acid (DRUG).
Who is sponsoring clinical trial NCT01649609?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01649609's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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