Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
| Status: | Completed |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/6/2016 |
| Start Date: | June 2014 |
| End Date: | March 2016 |
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.
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.
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.
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
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