Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

Completed · Phase 4

Conditions studied: Nephrotoxicity

In brief

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.

Key facts

Study ID

NCT02103855

Run by

Indiana University

People needed

6

Starts

2014-06-01

Expected to finish

2016-03-01

Last updated by the study team

2017-08-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pancreas transplant alone recipients
• EBV IgG positive
• Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy
• Maintained on a regimen of tacrolimus, sirolimus, mycophenolate

You may not qualify if…

• 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

Where it is running

• Indiana University Health, University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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