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NCT00455013 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
NCT00455013: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT00455013 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00455013, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant
Primary Outcome
AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant tre
Interventions
- DRUG Sirolimus
- DRUG Thymoglobulin
- DRUG Tacrolimus
- DRUG Belatacept
- DRUG Mycophenolate Mofetil (MMF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2007-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00455013 record still lists
NCT00455013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.
NCT00455013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00455013 about?
NCT00455013 is a clinical study titled "A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation". The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of...
What is the current status of trial NCT00455013?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2007-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00455013?
The interventions under investigation include: Sirolimus (DRUG), Thymoglobulin (DRUG), Tacrolimus (DRUG), Belatacept (DRUG), Mycophenolate Mofetil (MMF) (DRUG).
Who is sponsoring clinical trial NCT00455013?
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 NCT00455013's enrollment target sits among peer trials
93 766th of 2000 higher than 1,234 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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