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

University of Arizona

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplantation; New Onset Diabetes After Transplant

Treatments: Drug: Tacrolimus; Drug: Belatacept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01875224

IM103-303

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

Belatacept and CellCept

Experimental group

Description:

Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.

Treatment:

Drug: Belatacept

Tacrolimus and CellCept

Active Comparator group

Description:

Tacrolimus and CellCept taken twice daily based on patient response.

Treatment:

Drug: Tacrolimus