Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | August 2013 |
| End Date: | August 2016 |
| Contact: | Bruce Kaplan, MD |
| Phone: | 520-626-6371 |
Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression
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.
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.
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
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