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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
New Onset Diabetes After Transplant; Kidney Transplantation	Drug: Belatacept; Drug: Tacrolimus	Phase 4

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	32 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Official Title:	Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression
Study Start Date :	August 2013
Estimated Primary Completion Date :	August 2016
Estimated Study Completion Date :	August 2016

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Belatacept and CellCept; Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.	Drug: Belatacept; Other Name: Nulojix
Active Comparator: Tacrolimus and CellCept; Tacrolimus and CellCept taken twice daily based on patient response.	Drug: Tacrolimus; Standard administration of tacrolimus; Other Name: Prograf

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Increased insulin sensitivity [ Time Frame: 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)

2. Decreased insulin resistance [ Time Frame: 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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Bruce Kaplan, MD	520-626-6371
Contact: Rochelle Byrne, RN	520-626-9603	rbyrne@deptofmed.arizona.edu

Locations

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

Sponsors and Collaborators

University of Arizona

Bristol-Myers Squibb

Investigators

Principal Investigator:	Bruce Kaplan, MD	University of Arizona

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Bruce Kaplan, Chief of Abdominal Transplantation, University of Arizona
ClinicalTrials.gov Identifier:	NCT01875224 History of Changes
Other Study ID Numbers:	IM103-303
First Posted:	June 11, 2013
Last Update Posted:	June 11, 2013
Last Verified:	June 2013

Keywords provided by Bruce Kaplan, University of Arizona:

kidney transplant; diabetes after transplant; belatacept

Additional relevant MeSH terms:

Tacrolimus; Abatacept; Mycophenolic Acid; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Calcineurin Inhibitors; Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action; Antibiotics, Antineoplastic; Antineoplastic Agents; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents; Anti-Infective Agents; Antirheumatic Agents