Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression
Status unconfirmed · Phase 4
Conditions studied: New Onset Diabetes After Transplant, Kidney Transplantation
In brief
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.
Key facts
- Study ID
- NCT01875224
- Run by
- University of Arizona
- People needed
- 32
- Starts
- 2013-08-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2013-06-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Arizona — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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