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NCT00114777 · ClinicalTrials.gov registry record · Phase 3
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 595
- Enrollment target
NCT00114777: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00114777 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 595 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00114777, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 595 participants
- Enrollment target
Study Summary
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.
Primary Outcome
Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.
Interventions
- DRUG Cyclosporin A
- DRUG Belatacept Less Intensive Regimen (LI)
- DRUG Belatacept More Intensive Regimen (MI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 595 participants |
| Start Date | 2005-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT00114777 record still lists
NCT00114777 is an interventional study that assigns participants to a tested intervention. The registered 595 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclosporin A is the first listed.
NCT00114777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00114777 about?
NCT00114777 is a clinical study titled "Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant". The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.
What is the current status of trial NCT00114777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 595 participants. The study started on 2005-02. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00114777?
The interventions under investigation include: Cyclosporin A (DRUG), Belatacept Less Intensive Regimen (LI) (DRUG), Belatacept More Intensive Regimen (MI) (DRUG).
Who is sponsoring clinical trial NCT00114777?
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 NCT00114777's enrollment target sits among peer trials
595 640th of 2000 higher than 1,359 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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