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

NCT ID: NCT01875224

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-08-31

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.

Conditions

New Onset Diabetes After Transplant; Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Belatacept and CellCept

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

Group Type: EXPERIMENTAL

Belatacept

Intervention Type: DRUG

Tacrolimus and CellCept

Tacrolimus and CellCept taken twice daily based on patient response.

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: DRUG

Standard administration of tacrolimus

Interventions

Belatacept

Intervention Type: DRUG

Tacrolimus

Standard administration of tacrolimus

Intervention Type: DRUG

Other Intervention Names

Nulojix; Prograf

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Bruce Kaplan

Chief of Abdominal Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Kaplan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Central Contacts

Bruce Kaplan, MD

Role: CONTACT

520-626-6371

Rochelle Byrne, RN

Role: CONTACT

rbyrne@deptofmed.arizona.edu

520-626-9603

Facility Contacts

Rochelle Byrne, RN

Role: primary

rbyrne@deptofmed.arizona.edu

520-626-9603

Other Identifiers

IM103-303

Identifier Type: -

Identifier Source: org_study_id