Kidney Transplantation, New Onset Diabetes After Transplant
Conditions
Keywords
kidney transplant, diabetes after transplant, belatacept
Brief summary
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.
Interventions
DRUGBelatacept
DRUGTacrolimus
Standard administration of tacrolimus
Sponsors
Bristol-Myers Squibb
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increased insulin sensitivity | 12 months | 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) |
| Decreased insulin resistance | 12 months | 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 |
Countries
United States
Contacts
Primary ContactBruce Kaplan, MD
Backup ContactRochelle Byrne, RN
Outcome results
None listed