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NCT00866879 · ClinicalTrials.gov registry record · Phase 4
Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 275
- Enrollment target
NCT00866879: Completed Phase 4 study, sponsored by Northwestern University.
NCT00866879 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 275 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00866879, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 275 participants
- Enrollment target
Study Summary
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.
Primary Outcome
The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil/Cellcept ® and either tacrolimus/Prograf ® (Group #1) or mycophenolate mofetil/Cellcept ® and sirolimus/Rapamune® (Group #2) impacts the incidence of acute cellular rejection in post-kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.
Interventions
- DRUG Sirolimus
- OTHER Demographic Data, Medical History, and Donor Data
- PROCEDURE Blood Draws for Control Group
- PROCEDURE Blood Draws for Experimental Group
- PROCEDURE Donor Blood Draws
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2007-06 |
| Est. Completion | 2019-03 |
| Phase | Phase 4 |
What the finished NCT00866879 record still lists
NCT00866879 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.
NCT00866879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00866879 about?
NCT00866879 is a clinical study titled "Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients". This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® ...
What is the current status of trial NCT00866879?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 275 participants. The study started on 2007-06. Estimated completion is 2019-03.
What interventions are being tested in trial NCT00866879?
The interventions under investigation include: Sirolimus (DRUG), Demographic Data, Medical History, and Donor Data (OTHER), Blood Draws for Control Group (PROCEDURE), Blood Draws for Experimental Group (PROCEDURE), Donor Blood Draws (PROCEDURE).
Who is sponsoring clinical trial NCT00866879?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00866879's enrollment target sits among peer trials
275 311th of 2000 higher than 1,689 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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