Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression

Study Overview
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Brief Summary
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This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.

Official Title
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Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression

Conditions
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New Onset Diabetes After Transplant, Kidney Transplantation

Intervention / Treatment
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* Drug: Belatacept
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be given by patient. Adult patients between age 18 and 65 Thymoglobulin induction at the time of transplant Patient must be Epstein-Barr Virus seropositive Exclusion Criteria: Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant History of stroke, severe cardiac disease or cardiac failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belatacept and CellCept<br>Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily. | Drug: Belatacept<br> <br> * Other names: Nulojix;|
| Active Comparator: Tacrolimus and CellCept<br>Tacrolimus and CellCept taken twice daily based on patient response. | Drug: Tacrolimus<br>* Standard administration of tacrolimus<br>* Other names: Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased insulin sensitivity | Increase in insulin sensitivity (HOMA-S) as calculated below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA-S (insulin sensitivity) is calculated as 22.5 / (FIRI * FPG) | 12 months | 
| Decreased insulin resistance | Decreased insulin resistance (HOMA-IR) as measured below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA IR (insulin resistance) is calculated as (FIRI * FPG) / 22.5 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplant, diabetes after transplant, belatacept