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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
Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to randomization
Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, and 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on a stable medication regimen for my condition for at least 30 days.
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I received a kidney transplant more than 6 months ago.
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My kidney function has been stable for the last 3 months.
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I completed my initial COVID-19 vaccination series at least 6 weeks ago.
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I have been exposed to EBV in the past but currently show no signs of EBV replication.
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I am between 12 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, and 24 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
Proportion of participants who survive with a functional graft with estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 (updated Schwartz formula) at 24 months post-randomization
Secondary outcome measures
Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR)
Acute rejection: Severity of clinically suspected, biopsy confirmed rejection as determined by locally and centrally reviewed histopathology
Adherence to immunosuppressive medications as assessed by variation in calcineurin inhibitor pre-dose whole blood concentrations by summaries over time of monitored adherence to orally administered immunosuppressive medications
+30 more

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
Tacrolimus
2011
Completed Phase 4
~4740
Cyclosporine A
2014
Completed Phase 4
~3040
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Corticosteroids
2003
Completed Phase 4
~8270
Belatacept
2013
Completed Phase 4
~2210

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,631 Previous Clinical Trials
4,126,566 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people fit the qualifications for this clinical trial?

"Yes, an active search for participants is underway according to the listing on clinicaltrials.gov. This study was first made public on 7/21/2021 and updated most recently on 10/24/2022. 1 trial site is looking for 102 individuals to take part in the research."

Answered by AI

Would this research be appropriate for someone who is a senior citizen?

"This particular trial is for minors that 12 to 17 years old, however, there are many other options available both for children and adults. In total, 86 trials are meant for patients below 18 years old while 209 trials focus on individuals that are 65 or older."

Answered by AI

To whom is this research opportunity available?

"Adolescents, aged 12 to 17, who have received a renal allograft in the last 6 months and currently stable are eligible for this trial. In order to be selected, patients must also meet the following conditions: Must have been on a regimen of calcineurin inhibitors (CNI) with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to randomization, Have had clinically stable renal function during the"

Answered by AI

Has the FDA given its okay to shift patients from one drug (CNI) to another (belatacept) after a brief period of using both?

"Arm 1 of this Phase 3 clinical trial, which looks at the safety of conversion from a CNI- to belatacept-based regimen after a period of overlap, is estimated to be safe."

Answered by AI

Why do some patients need to take a combination of belatacept and CNI drugs?

"Arm 1: The administration of belatacept after a period of overlap is used to convert patients from a CNI-based regimen. This treatment can help prevent stem cell transplant rejection and manage other conditions like interstitial cystitis, nephrotic syndrome, and bone marrow transplantation."

Answered by AI

Are patients still being accepted for this experiment?

"According to the official website, this clinical trial is still looking for participants. The original posting was on July 21st, 2021 and there have been no changes since October 24th, 2022."

Answered by AI

Are there other examples in the medical literature of patients being transitioned from one immunosuppressant medication to another?

"At the moment, there are 264 on-going clinical trials investigating Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap. 36 of these studies are in Phase 3 and most originate from Philadelphia, Pennsylvania. However, research is being conducted at 1795 different locations for Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap."

Answered by AI
~44 spots leftby May 2026