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NCT03388008 · ClinicalTrials.gov registry record · Phase 2
Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT03388008: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT03388008 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03388008, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a pilot randomized controlled trial examining the feasibility of conducting a large scale randomized controlled trial of belatacept-based immunosuppression in lung transplantation. This pilot study will enroll 40 lung transplant recipients and randomize them to belatacept-based immunosuppression or standard of care. The primary endpoint of the study is the development of donor-specific HLA antibodies after transplantation. All study participants will be followed for a minimum of 12 months after transplantation.
Primary Outcome
The Outcome Measure is a composite primary endpoint of the development of donor-specific HLA antibodies, re-transplantation, or death. Testing for donor-specifc HLA antibodies was performed at study-specified time points using the single antigen bead assay at the study core lab. Donor-specific HLA antibodies were defined as reactivity with a mean fluorescence intensity (MFI) ≥ 2,000.
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Methylprednisolone
- DRUG Tacrolimus
- DRUG ATG
- DRUG Belatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 2 |
What the finished NCT03388008 record still lists
NCT03388008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT03388008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03388008 about?
NCT03388008 is a clinical study titled "Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation". This is a pilot randomized controlled trial examining the feasibility of conducting a large scale randomized controlled trial of belatacept-based immunosuppression in lung transplantation. This pilot study will enroll 40 lung transplant recipients and randomize them to belatacept-based immunosuppres...
What is the current status of trial NCT03388008?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2019-12-17. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT03388008?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Methylprednisolone (DRUG), Tacrolimus (DRUG), ATG (DRUG), Belatacept (DRUG).
Who is sponsoring clinical trial NCT03388008?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03388008's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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