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

June 7, 2013 updated by: Bruce Kaplan, University of Arizona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bruce Kaplan, MD
  • Phone Number: 520-626-6371

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Bruce Kaplan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Nulojix
Active Comparator: Tacrolimus and CellCept
Tacrolimus and CellCept taken twice daily based on patient response.
Drug: Tacrolimus
Standard administration of tacrolimus
Other Names:
  • Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Bruce Kaplan, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM103-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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