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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 is a NA study that has completed, run by Columbia University. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01649609
The ClinicalTrials.gov registry entry for NCT01649609 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT01649609 reports 0 study locations.
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.
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