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NCT00402168 · ClinicalTrials.gov registry record · Phase 2
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 173
- Enrollment target
NCT00402168: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT00402168 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 173 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402168, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 173 participants
- Enrollment target
Study Summary
The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied
Primary Outcome
Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on
Interventions
- DRUG Tacrolimus
- DRUG Cyclosporine A
- DRUG Belatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT00402168 record still lists
NCT00402168 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 3 interventions - of which Tacrolimus is the first listed.
NCT00402168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00402168 about?
NCT00402168 is a clinical study titled "A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids". The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied
What is the current status of trial NCT00402168?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 173 participants. The study started on 2007-01. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00402168?
The interventions under investigation include: Tacrolimus (DRUG), Cyclosporine A (DRUG), Belatacept (DRUG).
Who is sponsoring clinical trial NCT00402168?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402168's enrollment target sits among peer trials
173 397th of 2000 higher than 1,604 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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