Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Abatacept; Calcineurin Inhibitors; Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Pancreas transplant alone recipients

• EBV IgG positive

• Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy

• Maintained on a regimen of tacrolimus, sirolimus, mycophenolate

Exclusion Criteria:

• EBV IgG negative

• Not maintained on an immunosuppression regimen that contains tacrolimus

• Unable or unwilling to give informed consent

• Active infection

• History of malignancy post transplant

• Glomerular filtration rate < 15 mL/min