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NCT00035555 · ClinicalTrials.gov registry record · Phase 2
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
NCT00035555: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT00035555 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 230 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00035555, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).
Primary Outcome
No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.
Interventions
- DRUG Cyclosporine
- DRUG Mycophenolate mofetil (MMF)
- DRUG Belatacept
- DRUG Corticosteroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2001-03 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT00035555 record still lists
NCT00035555 is an interventional study that assigns participants to a tested intervention. The registered 230 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 (73% higher).
The record links to 0 conditions, and to 4 interventions - of which Cyclosporine is the first listed.
NCT00035555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00035555 about?
NCT00035555 is a clinical study titled "Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney". The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mell...
What is the current status of trial NCT00035555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2001-03. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00035555?
The interventions under investigation include: Cyclosporine (DRUG), Mycophenolate mofetil (MMF) (DRUG), Belatacept (DRUG), Corticosteroids (DRUG).
Who is sponsoring clinical trial NCT00035555?
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 NCT00035555's enrollment target sits among peer trials
230 257th of 2000 higher than 1,737 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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