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

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: Recruiting
• Conditions: Renal Allograft Recipients
• Intervention / Treatment: Biological: Belatacept; Drug: Tacrolimus; Drug: Cyclosporine A; Drug: Mycophenolate Mofetil; Drug: Enteric Coated Mycophenolate Sodium; Drug: Corticosteroids

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 3

Contacts and Locations

• Study Contact: 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
    • Hôpital 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant and graft survival: Proportion of participants who survive		6, 12, and 24 months
Participant and graft survival: Proportion of participants who experience death-censored graft loss		6, 12, and 24 months
Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR)		3, 6, 12, and 24 months
Acute rejection: Severity of clinically suspected, biopsy confirmed rejection as determined by locally and centrally reviewed histopathology		3, 6, 12, and 24 months
Renal function as assessed by: Serum creatinine concentration		Up to 24 months
Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation)		Up to 24 months
Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation		Up to 24 months
Renal function as assessed by: eGFR per Full Age Spectrum (FAS) equation of Potell et al		Up to 24 months
Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al		Up to 24 Months
Proteinuria, as assessed by urinary protein:creatinine ratio (UPCR), as determined from single-voided urine specimens		Up to 24 months
Slope of change in eGFR over time, as assessed by baseline-adjusted mean eGFR determinations at protocol-specified study visits		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		up to 24 months
Adherence to immunosuppressive medications, as assessed by: Variations in pre-dose concentrations of calcineurin inhibitor in whole blood		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		Up to 24 months
Adherence to immunosuppressive medications, as assessed by: Monitoring of compliance with monthly belatacept infusions		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		Up to 24 months
Mean blood pressure over time		Up to 24 months
Mean blood pressure changes from baseline over time		Up to 24 months
Intensity of antihypertensive drug therapy, defined as the total number of medications used to maintain BP control		Up to 24 months
Monitoring of safety laboratory parameters over time: Mean fasting lipid profiles		Up to 24 months
Monitoring of safety laboratory parameters over time: Fasting blood glucose concentrations		Up to 24 months
Monitoring of safety laboratory parameters over time: Hemoglobin A1c concentrations		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		6, 12, and 24 months
Immunogenicity of belatacept as determined by the proportion of participants with detectable serum anti-belatacept antibodies		6, 12, and 24 months
Belatacept pre-dose (C0) serum concentrations		Up to 24 months
Mean percent belatacept CD86 receptor occupancy		Baseline
Post-randomization changes from baseline percent belatacept CD86 receptor occupancy		6, 12, and 24 months
Safety and tolerability of belatacept following conversion: Incidence of Adverse Events (AEs)		up to 24 months
Safety and tolerability of belatacept following conversion: Incidence of Serious Adverse Events (SAEs)		Up to 24 months
Safety and tolerability of belatacept following conversion: Incidence of laboratory marked abnormalities		Up to 24 months
Proportion of participants within each stage of the Tanner staging scale	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)		Up to 24 months
Participant and graft survival: Proportion of participants who survive with a functioning graft		6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): December 30, 2032
• Study Completion (Estimated): June 30, 2034

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Conversion; Acute rejection; eGFR; Belatacept; Donor-specific antibodies; Immunosuppressive regimen; Calcineurin inhibitors (cyclosporine, tacrolimus); Adolescent kidney transplant recipients
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Fatty Acids; Lipids; Acids, Acyclic; Carboxylic Acids; Polycyclic Compounds; Antibodies; Immunoglobulins; Blood Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Macrocyclic Compounds; Peptides, Cyclic; Caproates; Cyclosporins; Abatacept; Mycophenolic Acid; Tacrolimus; Cyclosporine; Adrenal Cortex Hormones
• Other Study ID 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