Clinical trial NCT02103855: Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
Official title: Calcineurin Inhibitors to Belatacept Switch Study to Prevent the Progression of Kidney Disease in Pancreas Transplant Alone Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrotoxicity
Keywords: pancreas transplantation
immunosuppression
belatacept
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline and 1 year
measure: Serum Creatinine at Year 1
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Pancreas Transplant Rejection
timeFrame: 1 year
measure: Change From Baseline Serum Hemoglobin A1c
timeFrame: Baseline and 1 year
measure: Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health, University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Asif Sharfuddin, MD
role: PRINCIPAL_INVESTIGATOR
References: