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

NCT01875224 | Unknown Phase 4 DMC

• 1 other identifier: IM103-303
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

New Onset Diabetes After Transplant; Kidney Transplantation

Keywords

kidney transplant; diabetes after transplant; belatacept

Outcome Measures

Primary Outcomes (2)

• Increased insulin sensitivity

  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

  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

Study Arms (2)

Belatacept and CellCept

EXPERIMENTAL

Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.

Drug: Belatacept

Tacrolimus and CellCept

ACTIVE COMPARATOR

Tacrolimus and CellCept taken twice daily based on patient response.

Drug: Tacrolimus

Interventions

Belatacept DRUG

Also known as: Nulojix

Belatacept and CellCept

Tacrolimus DRUG

Standard administration of tacrolimus

Also known as: Prograf

Tacrolimus and CellCept

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Interventions

Abatacept; Tacrolimus

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Bruce Kaplan, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Kaplan, MD

CONTACT

520-626-6371

Rochelle Byrne, RN

CONTACT

520-626-9603; rbyrne@deptofmed.arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Abdominal Transplantation

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 11, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

US (1)