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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

  • Clinicaltrials.gov identifier

    NCT04877288

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 7, 2021

  • Last update posted

    May 7, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Renal Allograft Recipients
  • Intervention/Treatment: Biological: Belatacept
    Drug: Tacrolimus
    Drug: Cyclosporine A
    Drug: Mycophenolate Mofetil
    Drug: Enteric Coated Mycophenolate Sodium
    Drug: Corticosteroids
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 102 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official 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
  • Estimated Study Start Date: May 2021
  • Estimated Primary Completion Date: August 2026
  • Estimated Study Completion Date: December 2027

Arms and interventions

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

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

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 1. Safety and tolerability of belatacept following conversion: Incidence of Adverse Events (AEs) [ Time Frame: up to 24 months ]
  • 2. Immunogenicity of belatacept as determined by the proportion of participants with detectable serum anti-belatacept antibodies [ Time Frame: 6, 12, and 24 months ]
  • 3. Belatacept pre-dose (C0) serum concentrations [ Time Frame: Up to 24 months ]
  • 4. Mean percent belatacept CD86 receptor occupancy [ Time Frame: Baseline ]
  • 5. Participant and graft survival: Proportion of participants who survive with a functioning graft [ Time Frame: 6 and 12 months ]
  • 6. Participant and graft survival: Proportion of participants who survive [ Time Frame: 6, 12, and 24 months ]
  • 7. Participant and graft survival: Proportion of participants who experience death-censored graft loss [ Time Frame: 6, 12, and 24 months ]
  • 8. Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR) [ Time Frame: 3, 6, 12, and 24 months ]
  • 9. 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 ]
  • 10. Renal function as assessed by: Serum creatinine concentration [ Time Frame: Up to 24 months ]
  • 11. Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation) [ Time Frame: Up to 24 months ]
  • 12. Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation [ Time Frame: Up to 24 months ]
  • 13. Renal function as assessed by: eGFR per Full Age Spectrum (FAS) equation of Potell et al [ Time Frame: Up to 24 months ]
  • 14. Proteinuria, as assessed by urinary protein:creatinine ratio (UPCR), as determined from single-voided urine specimens [ Time Frame: Up to 24 months ]
  • 15. 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 ]
  • 16. 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 ]
  • 17. Adherence to immunosuppressive medications, as assessed by: Variations in pre-dose concentrations of calcineurin inhibitor in whole blood [ Time Frame: Up to 24 months ]
  • 18. 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 ]
  • 19. Adherence to immunosuppressive medications, as assessed by: Monitoring of compliance with monthly belatacept infusions [ Time Frame: Up to 24 months ]
  • 20. 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 ]
  • 21. Mean blood pressure over time [ Time Frame: Up to 24 months ]
  • 22. Mean blood pressure changes from baseline over time [ Time Frame: Up to 24 months ]
  • 23. Intensity of antihypertensive drug therapy, defined as the total number of medications used to maintain BP control [ Time Frame: Up to 24 months ]
  • 24. Monitoring of safety laboratory parameters over time: Mean fasting lipid profiles [ Time Frame: Up to 24 months ]
  • 25. Monitoring of safety laboratory parameters over time: Fasting blood glucose concentrations [ Time Frame: Up to 24 months ]
  • 26. Monitoring of safety laboratory parameters over time: Hemoglobin A1c concentrations [ Time Frame: Up to 24 months ]
  • 27. 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 ]
  • 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 Serious Adverse Events (SAEs) [ Time Frame: Up to 24 months ]
  • 30. Safety and tolerability of belatacept following conversion: Incidence of laboratory marked abnormalities [ Time Frame: Up to 24 months ]
  • 31. 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
  • 32. Linear growth (height) [ Time Frame: Up to 24 months ]

Eligibility Criteria

  • Ages Eligible for Study: 12 to 17 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 ≥1 calendar months 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 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

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

Locations

Belgium
Local Institution
Ghent

France
Local Institution
Bron

France
Local Institution
Paris

Germany
Local Institution
Hamburg

Germany
Local Institution
Heidelberg

Germany
Local Institution
Köln

Italy
Local Institution
Milano

Italy
Local Institution
Torino

Netherlands
Local Institution
Amsterdam

Spain
Local Institution
Barcelona

Spain
Local Institution
Rivas Vaciamadrid

Spain
Local Institution
Sevilla

United Kingdom
Local Institution
Manchester

United Kingdom
Local Institution
Nottingham

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04877288 History of Changes
  • Other Study ID Numbers: IM103-402, 2018-000237-12
  • First Posted: May 7, 2021 Key Record Dates
  • Last Update Posted: May 7, 2021
  • Last Verified: April 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Acute rejection
    Belatacept
    Calcineurin inhibitors (cyclosporine, tacrolimus)
    Conversion
    Donor-specific antibodies
    eGFR
    Immunosuppressive regimen
    Adolescent kidney transplant recipients