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NCT00896012 · ClinicalTrials.gov registry record · Phase 4
Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal
A Phase 4 study, sponsored by University at Buffalo.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
NCT00896012 is a Phase 4 study that has completed, run by University at Buffalo. The registered enrollment target is 58 participants.
The verdict
NCT00896012, a Phase 4 study, has completed, sponsored by University at Buffalo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
Study Summary
Current therapy to prevent organ rejection relies on the use of calcineurin inhibitors either cyclosporine or tacrolimus. Although these agents have been very successful in preventing early acute rejection, this success has not translated into improved long-term kidney transplant function. One of the important factors that leads to premature kidney transplant failure is chronic allograft nephropathy (CAN). CAN is characterized by progressive interstitial fibrosis or "scarring", vascular wall thickening, and finally glomerular sclerosis leading to slow progressive loss of kidney function. Calcineurin inhibitors have been shown to play an important role in the pathogens of CAN. Renal transplant recipients in whom calcineurin inhibitors are discontinued enjoy better and longer kidney function. Therefore, immunosuppressive strategies are being designed with the intention of withdrawing calcineurin inhibitors. The purpose of this trial is to test if tacrolimus can be safely substituted by sirolimus (Rapamycin) and this substitution will yield improved renal function, less CAN and better graft survival rates over the first year.
Interventions
- DRUG Tacrolimus
- PROCEDURE Kidney Biopsy
- DRUG Rapamune (sirolimus/rapamycin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00896012
The ClinicalTrials.gov registry entry for NCT00896012 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University at Buffalo, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tacrolimus is the first listed.
NCT00896012 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00896012 about?
NCT00896012 is a clinical study titled "Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal". Current therapy to prevent organ rejection relies on the use of calcineurin inhibitors either cyclosporine or tacrolimus. Although these agents have been very successful in preventing early acute rejection, this success has not translated into improved long-term kidney transplant function. One of th...
What is the current status of trial NCT00896012?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2008-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00896012?
The interventions under investigation include: Tacrolimus (DRUG), Kidney Biopsy (PROCEDURE), Rapamune (sirolimus/rapamycin) (DRUG).
Who is sponsoring clinical trial NCT00896012?
This trial is sponsored by University at Buffalo, which has 67 total clinical trials registered on ClinicalTrials.gov.
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