Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT02103855|
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nephrotoxicity||Drug: Belatacept||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Calcineurin Inhibitors to Belatacept Switch Study to Prevent the Progression of Kidney Disease in Pancreas Transplant Alone Recipients|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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.
Other Name: Nulojix
- Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline and 1 year ]Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept
- Serum Creatinine at Year 1 [ Time Frame: 1 year ]Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.
- Number of Participants With Pancreas Transplant Rejection [ Time Frame: 1 year ]Pancreas Rejection as measured by serum amylase, serum lipase.
- Change From Baseline Serum Hemoglobin A1c [ Time Frame: Baseline and 1 year ]Pancreas Transplant Function was measured by assessing change in Pre HbA1c to Post HbA1c at1 year after conversion.
- Pancreas Transplant Function as Measured by Fasting Serum Glucose Level. [ Time Frame: 1 Year ]Fasting Serum Glucose level measured at 1 year after conversion from Tacrolimus to Belatacept.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103855
|United States, Indiana|
|Indiana University Health, University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Asif Sharfuddin, MD||Indiana University School of Medicine|