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

Information source: University of Arizona
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: New Onset Diabetes After Transplant; Kidney Transplantation

Intervention: Belatacept (Drug); Tacrolimus (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Arizona

Official(s) and/or principal investigator(s):
Bruce Kaplan, MD, Principal Investigator, Affiliation: University of Arizona

Overall contact:
Bruce Kaplan, MD, Phone: 520-626-6371

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.

Clinical Details

Official title: Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Increased insulin sensitivity

Decreased insulin resistance

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Bruce Kaplan, MD, Phone: 520-626-6371

University of Arizona, Tucson, Arizona 85724, United States; Not yet recruiting
Rochelle Byrne, RN, Phone: 520-626-9603, Email: rbyrne@deptofmed.arizona.edu
Bruce Kaplan, MD, Principal Investigator
Additional Information

Starting date: August 2013
Last updated: June 7, 2013

Page last updated: August 23, 2015

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