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NCT00256750 · ClinicalTrials.gov registry record · Phase 3
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 738
- Enrollment target
NCT00256750: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00256750 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 738 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256750, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 738 participants
- Enrollment target
Study Summary
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.
Primary Outcome
Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.
Interventions
- DRUG Cyclosporine (CsA)
- DRUG Belatacept LI (less intensive)
- DRUG Belatacept MI (more intensive)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2005-03 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT00256750 record still lists
NCT00256750 is an interventional study that assigns participants to a tested intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Cyclosporine (CsA) is the first listed.
NCT00256750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256750 about?
NCT00256750 is a clinical study titled "Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)". The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug s...
What is the current status of trial NCT00256750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 738 participants. The study started on 2005-03. Estimated completion is 2015-04.
What interventions are being tested in trial NCT00256750?
The interventions under investigation include: Cyclosporine (CsA) (DRUG), Belatacept LI (less intensive) (DRUG), Belatacept MI (more intensive) (DRUG).
Who is sponsoring clinical trial NCT00256750?
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 NCT00256750's enrollment target sits among peer trials
738 479th of 2000 higher than 1,522 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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