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NCT03591380 · ClinicalTrials.gov registry record · Phase 2
CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03591380: Clinical Trial Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT03591380 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03591380, a Phase 2 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in helping prevent new donor specific antibodies (DSA) after transplantation. The presence of DSA increases the risk that the kidney transplant recipient's body will reject the new kidney. The investigators are doing this research because it is estimated that greater than 50% of kidney transplant failures are attributed to antibodies produced in the body, that attack the transplanted organ as a foreign object. DSA produced in the body after a kidney transplant, is thought to occur in 20-50% of patients and is associated with a low likelihood that the organ recipient's body will accept the new kidney. A major unmet need in the kidney transplant area are safe and effective therapies to prevent DSA after transplantation.
Primary Outcome
Use descriptive statistics to describe the rate of de novo DSA development as determined using Luminex, graft survival and function as determined by serum creatinine/eGFR and urine protein, rates of acute cellular and antibody mediated rejection.
Interventions
- DRUG Belimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-05-14 |
| Est. Completion | 2021-12-03 |
| Phase | Phase 2 |
Why NCT03591380 stopped before completion
NCT03591380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Belimumab is the first listed.
NCT03591380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03591380 about?
NCT03591380 is a clinical study titled "CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients". The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in helping prevent new donor specific antibodies (DSA) after transplantati...
What is the current status of trial NCT03591380?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2019-05-14. Estimated completion is 2021-12-03.
What interventions are being tested in trial NCT03591380?
The interventions under investigation include: Belimumab (DRUG).
Who is sponsoring clinical trial NCT03591380?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03591380's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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