Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

Nephrotoxicity Clinical Trial

Official title:

Calcineurin Inhibitors to Belatacept Switch Study to Prevent the Progression of Kidney Disease in Pancreas Transplant Alone Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103855
• Other study ID #: BMS 103-337
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2014
• Last updated: August 25, 2017
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrotoxicity

Intervention

Drug:
• Belatacept

Locations

Country	Name	City	State
United States	Indiana University Health, University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)	Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept	Baseline and 1 year
Primary	Serum Creatinine at Year 1	Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.	1 year
Secondary	Number of Participants With Pancreas Transplant Rejection	Pancreas Rejection as measured by serum amylase, serum lipase.	1 year
Secondary	Change From Baseline Serum Hemoglobin A1c	Pancreas Transplant Function was measured by assessing change in Pre HbA1c to Post HbA1c at1 year after conversion.	Baseline and 1 year
Secondary	Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.	Fasting Serum Glucose level measured at 1 year after conversion from Tacrolimus to Belatacept.	1 Year