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Immunosuppressant

Belatacept Regimen for Kidney Transplant Recipients

Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Banff 97 grade IIA or higher acute cellular rejection (or equivalent), or treatment with plasmapheresis or rituximab for any acute rejection at any time with the current allograft
Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether it's better for teens with kidney transplants to switch to a different immunosuppressive drug regimen.

Who is the study for?
This trial is for adolescents aged 12 to <18 who have had a kidney transplant at least 6 months ago, are vaccinated against SARS-CoV-2, and show no current EBV infection. They must be on a stable calcineurin inhibitor regimen with mycophenolate and possibly corticosteroids. Those previously treated with belatacept or having certain rejection episodes or TB can't participate.
What is being tested?
The study compares the effects of switching adolescent kidney transplant recipients from their current calcineurin inhibitor-based treatment (like Tacrolimus) to a Belatacept-based regimen versus continuing their existing treatment. It also looks at how well they stick to their medication schedules.
What are the potential side effects?
Potential side effects may include immune system changes leading to increased risk of infections, possible drug reactions, and other complications related to altering immunosuppressive therapy in this population.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a severe rejection episode with my current organ transplant.
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I have been treated with belatacept or was in a belatacept trial with my current transplant.
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My current transplant is experiencing rejection confirmed by a biopsy.
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I have or had untreated or active TB.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Proportion of participants within each stage of the Tanner staging scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlapExperimental Treatment6 Interventions
Conversion followed by tapering and discontinuation of the calcineurin inhibitor (CNI)
Group II: Arm 2: Continue calcineurin inhibitor-based regimenActive Control5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Tacrolimus
2019
Completed Phase 4
~5510
Cyclosporine A
2014
Completed Phase 4
~3800
Belatacept
2013
Completed Phase 4
~2210
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,969 Total Patients Enrolled

Media Library

Belatacept (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04877288 — Phase 3
Kidney Transplant Recipients Research Study Groups: Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap, Arm 2: Continue calcineurin inhibitor-based regimen
Kidney Transplant Recipients Clinical Trial 2023: Belatacept Highlights & Side Effects. Trial Name: NCT04877288 — Phase 3
Belatacept (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04877288 — Phase 3
~30 spots leftby May 2026
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