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Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02103855
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Information provided by (Responsible Party):
Asif Sharfuddin, Indiana University

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.

Condition or disease Intervention/treatment Phase
Nephrotoxicity Drug: Belatacept Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arm Intervention/treatment
Experimental: 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.

Drug: Belatacept
Other Name: Nulojix

Primary Outcome Measures :
  1. 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

  2. Serum Creatinine at Year 1 [ Time Frame: 1 year ]
    Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.

Secondary Outcome Measures :
  1. Number of Participants With Pancreas Transplant Rejection [ Time Frame: 1 year ]
    Pancreas Rejection as measured by serum amylase, serum lipase.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02103855

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United States, Indiana
Indiana University Health, University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Principal Investigator: Asif Sharfuddin, MD Indiana University School of Medicine
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Responsible Party: Asif Sharfuddin, Asif A Sharfuddin, MD, Indiana University Identifier: NCT02103855    
Other Study ID Numbers: BMS 103-337
First Posted: April 4, 2014    Key Record Dates
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017
Last Verified: August 2017
Keywords provided by Asif Sharfuddin, Indiana University:
pancreas transplantation
Additional relevant MeSH terms:
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Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents