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

University of Arizona32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

New Onset Diabetes After Transplant Kidney Transplantation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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