Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

NCT ID: NCT02103855

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-03-31

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.

Conditions

Nephrotoxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

belatacept

Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.

Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.

Group Type: EXPERIMENTAL

Belatacept

Intervention Type: DRUG

Interventions

Belatacept

Intervention Type: DRUG

Other Intervention Names

Nulojix

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Asif Sharfuddin

Asif A Sharfuddin, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asif Sharfuddin, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Health, University Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

BMS 103-337

Identifier Type: -

Identifier Source: org_study_id