Nephrotoxicity Clinical Trial
Official title:
Calcineurin Inhibitors to Belatacept Switch Study to Prevent the Progression of Kidney Disease in Pancreas Transplant Alone Recipients
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.
Nephrotoxicity is a major complication of current immunosuppression regimens used in
transplantation. Pancreas transplantation has been increasedly performed to manage labile
diabetes mellitus during the last few decades and survival rates of pancreatic grafts are
improving. One of the challenges that is faced following pancreas transplantation alone are
pathologic changes from diabetes frequently seen in native kidneys in the pancreas transplant
recipients. High levels of calcineurin inhibitors (CNI) have been identified as risk factors
for decline in kidney function and progression to end-stage renal disease. The objective of
this trial is to take subjects who have biopsy proven CNI toxicity off of their CNI and begin
belatacept, which is not a CNI.
The hypothesis is by switching the pancreas transplant subject with documented CNI kidney
toxicity to belatacept will slow the progression of chronic kidney disease.
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