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Belatacept Switch for CNI Toxicity in Pancreas Transplant
NCT02103855Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2014
- Primary completion
- Mar 2016
- Countries
- 1
- Sponsor
- Indiana University
- Modality
- Fc-Fusion Proteins
- Drugs
- belatacept
- Conditions
- calcineurin inhibitor nephrotoxicity
01
Overview
Phase 4, open-label, single-arm trial of belatacept in calcineurin inhibitor nephrotoxicity, sponsored by Indiana University. Primary endpoints: Change From Baseline in Serum Estimated Glomerular Filtration Rate at 1 year and Serum Creatinine at Year 1. Started Jun 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Belatacept Switch
Switch from Tacrolimus to Belatacept while maintaining Sirolimus and Mycophenolate.
03
Who it enrols
Pancreas transplant alone recipients with biopsy-proven calcineurin inhibitor toxicity on native kidney biopsy, maintained on a regimen of tacrolimus, sirolimus, and mycophenolate, and EBV IgG positive.
04
Endpoints
Primary
Change From Baseline in Serum Estimated Glomerular Filtration Rate
Serum Creatinine at Year 1
Secondary
Number of Participants With Pancreas Transplant Rejection
Change From Baseline Serum Hemoglobin A1c
Pancreas Transplant Function as Measured by Fasting Serum Glucose Level
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