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Immunosuppressant

Belatacept and CellCept for Kidney Transplant

Phase 4
Waitlist Available
Led By Bruce Kaplan, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.

Eligible Conditions
  • Diabetes
  • Kidney Transplant

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decreased insulin resistance
Increased insulin sensitivity

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193
67%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Belatacept and CellCeptExperimental Treatment1 Intervention
Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.
Group II: Tacrolimus and CellCeptActive Control1 Intervention
Tacrolimus and CellCept taken twice daily based on patient response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate mofetil
FDA approved

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,562 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,000 Total Patients Enrolled
Bruce Kaplan, MDPrincipal InvestigatorUniversity of Arizona

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Apr 2025