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

Phase 4

• Conditions: New Onset Diabetes After Transplant; Kidney Transplantation
• Interventions: Drug: Belatacept; Drug: Tacrolimus

• Registration Number: NCT01875224
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-07
• Last Update Submitted: 2013-06-07
• Study First Posted: 2013-06-11
• Last Update Posted: 2013-06-11
• Study Start: 2013-08
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Belatacept and CellCept	Belatacept	Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.
Tacrolimus and CellCept	Tacrolimus	Tacrolimus and CellCept taken twice daily based on patient response.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States