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NCT Number: NCT04877288

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

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.

Recruiting

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Italiano de Buenos Aires, ABB, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belatacept

Biological

Specified dose on specified days

Other names: Nulojix

Tacrolimus

Drug

Specified dose on specified days

Cyclosporine A

Drug

Specified dose on specified days

Mycophenolate mofetil

Drug

Specified dose on specified days

Enteric Coated Mycophenolate Sodium

Drug

Specified dose on specified days

Corticosteroids

Drug

Specified dose on Specified days

Primary outcomes

  1. 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

Secondary outcomes

  1. Participant and graft survival: Proportion of participants who survive with a functioning graft

    Time frame: 6, 12 and 24 months

  2. Participant and graft survival: Proportion of participants who survive

    Time frame: 6, 12, and 24 months

  3. Participant and graft survival: Proportion of participants who experience death-censored graft loss

    Time frame: 6, 12, and 24 months

  4. Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR)

    Time frame: 3, 6, 12, and 24 months

  5. 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

  6. Renal function as assessed by: Serum creatinine concentration

    Time frame: Up to 24 months

  7. Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation)

    Time frame: Up to 24 months

  8. Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation

    Time frame: Up to 24 months

  9. Renal function as assessed by: eGFR per Full Age Spectrum (FAS) equation of Potell et al

    Time frame: Up to 24 months

  10. Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al

    Time frame: Up to 24 Months

  11. Proteinuria, as assessed by urinary protein:creatinine ratio (UPCR), as determined from single-voided urine specimens

    Time frame: Up to 24 months

  12. 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

  13. 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

  14. Adherence to immunosuppressive medications, as assessed by: Variations in pre-dose concentrations of calcineurin inhibitor in whole blood

    Time frame: Up to 24 months

  15. 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

  16. Adherence to immunosuppressive medications, as assessed by: Monitoring of compliance with monthly belatacept infusions

    Time frame: Up to 24 months

  17. 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

  18. Mean blood pressure over time

    Time frame: Up to 24 months

  19. Mean blood pressure changes from baseline over time

    Time frame: Up to 24 months

  20. Intensity of antihypertensive drug therapy, defined as the total number of medications used to maintain BP control

    Time frame: Up to 24 months

  21. Monitoring of safety laboratory parameters over time: Mean fasting lipid profiles

    Time frame: Up to 24 months

  22. Monitoring of safety laboratory parameters over time: Fasting blood glucose concentrations

    Time frame: Up to 24 months

  23. Monitoring of safety laboratory parameters over time: Hemoglobin A1c concentrations

    Time frame: Up to 24 months

  24. 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

  25. Immunogenicity of belatacept as determined by the proportion of participants with detectable serum anti-belatacept antibodies

    Time frame: 6, 12, and 24 months

  26. Belatacept pre-dose (C0) serum concentrations

    Time frame: Up to 24 months

  27. Mean percent belatacept CD86 receptor occupancy

    Time frame: Baseline

  28. Post-randomization changes from baseline percent belatacept CD86 receptor occupancy

    Time frame: 6, 12, and 24 months

  29. Safety and tolerability of belatacept following conversion: Incidence of Adverse Events (AEs)

    Time frame: up to 24 months

  30. Safety and tolerability of belatacept following conversion: Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 24 months

  31. Safety and tolerability of belatacept following conversion: Incidence of laboratory marked abnormalities

    Time frame: Up to 24 months

  32. 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

  33. Linear growth (height)

    Time frame: Up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2032
Study completion
2034
First posted
May 7, 2021
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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