A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

February 2, 2026 updated by: Bristol-Myers Squibb

A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Not yet recruiting
        • Local Institution - 0062
        • Contact:
          • Site 0062
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Not yet recruiting
        • Local Institution - 0060
        • Contact:
          • Site 0060
  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent-Paediatric Nephrology and Rheumatology Department
        • Contact:
          • Agnieszka Prytula, Site 0047
          • Phone Number: +3293320368
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Bordeaux University Hospital - Pellegrin-Pediatrics
        • Contact:
          • Jerome Harambat, Site 0056
          • Phone Number: +33661986263
      • Bron, France, 69677
        • Recruiting
        • Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique
        • Contact:
          • Anne-Laure SELLIER-LECLERC, Site 0028
          • Phone Number: +33427856128
      • Marseille, France, 13005
        • Recruiting
        • Hopital de la Timone
        • Contact:
          • Florentine Garaix, Site 0054
          • Phone Number: +334 91 38 83 83
      • Paris, France, 75015
        • Recruiting
        • Hopital Necker
        • Contact:
          • Olivia Boyer, Site 0027
          • Phone Number: +33689031066
      • Paris, France, 75019
        • Recruiting
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
        • Contact:
          • Julien Hogan, Site 0029
          • Phone Number: 33638691391
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
        • Contact:
          • Gwenaelle Roussey, Site 0055
          • Phone Number: +33253482237
  • Germany
      • Cologne, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia
        • Contact:
          • Lutz Weber, Site 0010
          • Phone Number: 0049-173-5842620
      • Hamburg, Germany, 20246
        • Recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
      • Heidelberg, Germany, 69120
        • Recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45122
        • Recruiting
        • Universitaetsklinikum Essen
        • Contact:
          • Lars Pape, Site 0057
          • Phone Number: +495115323283
  • Italy
      • Milan, Italy, 20122
        • Withdrawn
        • Local Institution - 0030
      • Torino, Italy, 10126
        • Recruiting
        • Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale
        • Contact:
          • Licia Peruzzi, Site 0036
          • Phone Number: 0039 0113135365
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
        • Contact:
          • ENRICO VERRINA, Site 0059
          • Phone Number: 003901056362630
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Emma Children (AMC)
        • Contact:
          • Antonia Bouts, Site 0015
          • Phone Number: 0031610061279
  • Norway
      • Oslo, Norway, N-0027
        • Withdrawn
        • Local Institution - 0061
  • Spain
      • Barcelona, Spain, 08035
        • Completed
        • Local Institution - 0001
      • Rivas-Vaciamadrid, Spain, 28523
        • Completed
        • Local Institution - 0012
      • Seville, Spain, 41013
        • Completed
        • Local Institution - 0003
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Completed
        • Local Institution - 0008
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team
        • Contact:
          • Jon Jin Kim, Site 0009
          • Phone Number: 01159249924
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Withdrawn
        • Local Institution - 0042
    • California
      • Los Angeles, California, United States, 90095
        • Withdrawn
        • Local Institution - 0041
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Withdrawn
        • Local Institution - 0014
    • Florida
      • Hollywood, Florida, United States, 33021
        • Withdrawn
        • Local Institution - 0022
      • Miami, Florida, United States, 33136
        • Withdrawn
        • Local Institution - 0045
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Withdrawn
        • Local Institution - 0049
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Local Institution - 0033
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Withdrawn
        • Local Institution - 0017
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Withdrawn
        • Local Institution - 0044
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Withdrawn
        • Local Institution - 0043
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Withdrawn
        • Local Institution - 0024
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Withdrawn
        • Local Institution - 0025
      • Cleveland, Ohio, United States, 44124
        • Withdrawn
        • Local Institution - 0048
    • Oregon
      • Portland, Oregon, United States, 97239
        • Withdrawn
        • Local Institution - 0052
    • Washington
      • Seattle, Washington, United States, 98105
        • Withdrawn
        • Local Institution - 0038

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female adolescents 12 to less than 18 years of age
  • Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment
  • 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
  • Clinically stable renal function during the 12-week period prior to screening, in the opinion of the investigator and based on protocol-defined criteria for proteinuria and estimated glomerular filtration rate (eGFR)
  • Serologic evidence of past exposure to Epstein-Barr virus (EBV) and current absence of EBV DNA replication at or prior to renal transplantation and during the Screening period
  • Completion of an initial course of SARS-CoV-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment

Exclusion Criteria:

  • Recipients with EBV serostatus negative or unknown at screening or at transplant
  • Treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment
  • Biopsy-confirmed antibody-mediated acute rejection at any time with the current allograft
  • 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
  • Current evidence or past history of active or inadequately treated latent tuberculosis (TB) infection
  • Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft

Other inclusion/exclusion criteria apply

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap
Conversion followed by tapering and discontinuation of the calcineurin inhibitor (CNI)
Biological: Belatacept
Specified dose on specified days
Other Names:
  • Nulojix
Drug: Tacrolimus
Specified dose on specified days
Drug: Cyclosporine A
Specified dose on specified days
Drug: Mycophenolate Mofetil
Specified dose on specified days
Drug: Enteric Coated Mycophenolate Sodium
Specified dose on specified days
Drug: Corticosteroids
Specified dose on Specified days
Active Comparator: Arm 2: Continue calcineurin inhibitor-based regimen
Drug: Tacrolimus
Specified dose on specified days
Drug: Cyclosporine A
Specified dose on specified days
Drug: Mycophenolate Mofetil
Specified dose on specified days
Drug: Enteric Coated Mycophenolate Sodium
Specified dose on specified days
Drug: Corticosteroids
Specified dose on Specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant and graft survival: Proportion of participants who survive
Time Frame: 6, 12, and 24 months
6, 12, and 24 months
Participant and graft survival: Proportion of participants who experience death-censored graft loss
Time Frame: 6, 12, and 24 months
6, 12, and 24 months
Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR)
Time Frame: 3, 6, 12, and 24 months
3, 6, 12, and 24 months
Acute rejection: Severity of clinically suspected, biopsy confirmed rejection as determined by locally and centrally reviewed histopathology
Time Frame: 3, 6, 12, and 24 months
3, 6, 12, and 24 months
Renal function as assessed by: Serum creatinine concentration
Time Frame: Up to 24 months
Up to 24 months
Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation)
Time Frame: Up to 24 months
Up to 24 months
Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation
Time Frame: Up to 24 months
Up to 24 months
Renal function as assessed by: eGFR per Full Age Spectrum (FAS) equation of Potell et al
Time Frame: Up to 24 months
Up to 24 months
Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al
Time Frame: Up to 24 Months
Up to 24 Months
Proteinuria, as assessed by urinary protein:creatinine ratio (UPCR), as determined from single-voided urine specimens
Time Frame: Up to 24 months
Up to 24 months
Slope of change in eGFR over time, as assessed by baseline-adjusted mean eGFR determinations at protocol-specified study visits
Time Frame: Up to 24 months
Up to 24 months
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
Time Frame: up to 24 months
up to 24 months
Adherence to immunosuppressive medications, as assessed by: Variations in pre-dose concentrations of calcineurin inhibitor in whole blood
Time Frame: Up to 24 months
Up to 24 months
Adherence to immunosuppressive medications, as assessed by: 7-day recall of missed and late doses of each orally administered immuno-suppressive medication at protocol-specified study visits
Time Frame: Up to 24 months
Up to 24 months
Adherence to immunosuppressive medications, as assessed by: Monitoring of compliance with monthly belatacept infusions
Time Frame: Up to 24 months
Up to 24 months
Adherence to immunosuppressive medications, as assessed by: Periodic review of parents' and patients' perceived barriers to adherence to the prescribed immunosuppressive medications regimen
Time Frame: Up to 24 months
Up to 24 months
Mean blood pressure over time
Time Frame: Up to 24 months
Up to 24 months
Mean blood pressure changes from baseline over time
Time Frame: Up to 24 months
Up to 24 months
Intensity of antihypertensive drug therapy, defined as the total number of medications used to maintain BP control
Time Frame: Up to 24 months
Up to 24 months
Monitoring of safety laboratory parameters over time: Mean fasting lipid profiles
Time Frame: Up to 24 months
Up to 24 months
Monitoring of safety laboratory parameters over time: Fasting blood glucose concentrations
Time Frame: Up to 24 months
Up to 24 months
Monitoring of safety laboratory parameters over time: Hemoglobin A1c concentrations
Time Frame: Up to 24 months
Up to 24 months
Donor Specific antibodies (DSA): Proportion of participants with pre-existing anti-human leukocyte antigen (HLA) DSAs at baseline and with de novo anti-HLA DSA post-randomization
Time Frame: 6, 12, and 24 months
6, 12, and 24 months
Immunogenicity of belatacept as determined by the proportion of participants with detectable serum anti-belatacept antibodies
Time Frame: 6, 12, and 24 months
6, 12, and 24 months
Belatacept pre-dose (C0) serum concentrations
Time Frame: Up to 24 months
Up to 24 months
Mean percent belatacept CD86 receptor occupancy
Time Frame: Baseline
Baseline
Post-randomization changes from baseline percent belatacept CD86 receptor occupancy
Time Frame: 6, 12, and 24 months
6, 12, and 24 months
Safety and tolerability of belatacept following conversion: Incidence of Adverse Events (AEs)
Time Frame: up to 24 months
up to 24 months
Safety and tolerability of belatacept following conversion: Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 24 months
Up to 24 months
Safety and tolerability of belatacept following conversion: Incidence of laboratory marked abnormalities
Time Frame: Up to 24 months
Up to 24 months
Proportion of participants within each stage of the Tanner staging scale
Time Frame: Up to 24 months
The Tanner scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult
Up to 24 months
Linear growth (height)
Time Frame: Up to 24 months
Up to 24 months
Participant and graft survival: Proportion of participants who survive with a functioning graft
Time Frame: 6, 12 and 24 months
6, 12 and 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM103-402
  • 2022-501677-39 (Other Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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