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

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ClinicalTrials.gov Identifier: NCT01875224
Recruitment Status : Unknown
Verified June 2013 by Bruce Kaplan, University of Arizona.
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2013
Last Update Posted : June 11, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bruce Kaplan, University of Arizona

Study Description
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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
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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

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Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
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