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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02327403
The ClinicalTrials.gov registry entry for NCT02327403 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 10 other Proteinuria trials with a reported enrollment target (93% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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