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NCT02327403 · ClinicalTrials.gov registry record · Phase 2
Belatacept Conversion in Proteinuric Kidney Transplant Recipients
A Phase 2 study of Proteinuria, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02327403: Completed Phase 2 study of Proteinuria, sponsored by Brigham and Women's Hospital.
NCT02327403 is a Phase 2 study of Proteinuria that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 15 participants, below the 205-participant average among 10 other Proteinuria trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02327403, a Phase 2 study of Proteinuria, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Proteinuria develops in about 30% of kidney transplant recipients and is a strong predictor of graft loss. The amount of proteinuria has a direct correlation with the risk of graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent graft loss in transplant recipients, since ACE inhibitors carry a number of limitations in the transplant setting, including significant reduction in renal function, anemia and hyperkalemia. Preliminary data: B7-1 is expressed at significant levels in about 10% of kidney allograft biopsies with predominance in patients with proteinuria. Hypothesis: We hypothesize that B7-1 targeting therapy may reduce proteinuria and improve graft survival in proteinuric transplant recipients that have B7-1 staining on allografts. In addition, the absence of CNI nephrotoxicity and the potential protective effect of Belatacept on DSA production may be of benefit in this subset of transplant patients. Objectives: Primary: Determine the effect of Belatacept conversion in reducing proteinuria by 25% at 12 months in renal transplant recipients (≥1gram/d) that are either B7-1-positive or negative on kidney biopsy. Secondary: Assess the effect of Belatacept conversion in the percent change of renal function from baseline to 12 months; donor-specific anti-HLA antibodies presence and intensity (MFI); correlation of B7-1 positivity on immunofluorescence on biopsy with B7-1-expression in urine extracellular vesicles; adverse events; acute rejection episodes; blood pressure control; new onset diabetes; hyperlipidemia; graft survival; and patient survival.
Primary Outcome
Change in proteinuria by 25%: daily proteinuria is estimated by spot urine protein (mg/dL) to creatinine (mg/dL) ratio at baseline (before the belatacept conversion) and post-conversion 12 months; and interval % change was calculated by getting the ratio of difference between the two time points to the baseline value.
Conditions Studied
Interventions
- DRUG Belatacept
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-10 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 2 |
What the finished NCT02327403 record still lists
NCT02327403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 205-participant average among 10 other Proteinuria trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Proteinuria appearing as the primary indexed condition, and to 1 intervention - of which Belatacept is the first listed.
NCT02327403 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02327403 about?
NCT02327403 is a clinical study titled "Belatacept Conversion in Proteinuric Kidney Transplant Recipients". Background: Proteinuria develops in about 30% of kidney transplant recipients and is a strong predictor of graft loss. The amount of proteinuria has a direct correlation with the risk of graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent graft loss in transplant rec...
What is the current status of trial NCT02327403?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2015-10. Estimated completion is 2020-10-01.
What conditions does trial NCT02327403 study?
This clinical trial studies the following conditions: Proteinuria.
What interventions are being tested in trial NCT02327403?
The interventions under investigation include: Belatacept (DRUG).
Who is sponsoring clinical trial NCT02327403?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02327403 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02327403's enrollment target sits among peer trials
15 10th of 10 higher than 1 of 10 other Proteinuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Proteinuria 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.
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