A Phase 4 interventional study of Belatacept and Tacrolimus in New Onset Diabetes After Transplant and Kidney Transplantation, sponsored by University of Arizona. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-11.
Sponsored by University of Arizona · Phase 4 and Interventional
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.
University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.
Drug: Belatacept
Tacrolimus and CellCept taken twice daily based on patient response.
Drug: Tacrolimus
Also known as: Nulojix
Standard administration of tacrolimus
Also known as: Prograf
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
Time frame: 12 months
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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University of Arizona