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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified June 2013 by University of Arizona

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

Bruce Kaplan, University of Arizona

ClinicalTrials.gov Identifier:

NCT01875224

First received: May 29, 2013

Last updated: June 7, 2013

Last verified: June 2013

History of Changes

Purpose

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	Intervention	Phase
New Onset Diabetes After Transplant Kidney Transplantation	Drug: Belatacept Drug: Tacrolimus	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Kidney Transplantation

Drug Information available for: Tacrolimus Belatacept

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:

Increased insulin sensitivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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


Estimated Enrollment:	32
Study Start Date:	August 2013
Estimated Study Completion Date:	August 2016
Estimated Primary Completion Date:	August 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875224

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

No publications provided


Responsible Party:	Bruce Kaplan, Chief of Abdominal Transplantation, University of Arizona
ClinicalTrials.gov Identifier:	NCT01875224 History of Changes
Other Study ID Numbers:	IM103-303
Study First Received:	May 29, 2013
Last Updated:	June 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arizona:


kidney transplant diabetes after transplant belatacept

Additional relevant MeSH terms:


Tacrolimus Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

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