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NCT00578448 · ClinicalTrials.gov registry record · Phase 2
Belatacept Pharmacokinetic Trial in Renal Transplantation
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00578448: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT00578448 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578448, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication
Primary Outcome
Pharmacokinetic (PK) sampling started from pre-dose (0 hour) on Day 84 and ended at 672 hour (h) on Day 112 (between Weeks 12 to 16). The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method and measured as nanograms/milliliter (ng/mL). Less than the lower limit of quantification (LLQ), 3.000 ng/mL concentration value was treated as missing.
Interventions
- DRUG Belatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00578448 record still lists
NCT00578448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Belatacept is the first listed.
NCT00578448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00578448 about?
NCT00578448 is a clinical study titled "Belatacept Pharmacokinetic Trial in Renal Transplantation". The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication
What is the current status of trial NCT00578448?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2008-03. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00578448?
The interventions under investigation include: Belatacept (DRUG).
Who is sponsoring clinical trial NCT00578448?
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 NCT00578448's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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