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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Belatacept
  Specified dose on specified days
• Препарат Tacrolimus
  Specified dose on specified days
• Препарат Cyclosporine A
  Specified dose on specified days
• Препарат Mycophenolate Mofetil
  Specified dose on specified days
• Препарат Enteric Coated Mycophenolate Sodium
  Specified dose on specified days
• Препарат Corticosteroids
  Specified dose on Specified days

Первичные конечные точки

• 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 [Срок оценки: 24 months]

Вторичные конечные точки (12)

• Participant and graft survival: Proportion of participants who survive with a functioning graft [Срок оценки: 6, 12 and 24 months]
• Participant and graft survival: Proportion of participants who survive [Срок оценки: 6, 12, and 24 months]
• Participant and graft survival: Proportion of participants who experience death-censored graft loss [Срок оценки: 6, 12, and 24 months]
• Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR) [Срок оценки: 3, 6, 12, and 24 months]
• Acute rejection: Severity of clinically suspected, biopsy confirmed rejection as determined by locally and centrally reviewed histopathology [Срок оценки: 3, 6, 12, and 24 months]
• Renal function as assessed by: Serum creatinine concentration [Срок оценки: Up to 24 months]
• Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation) [Срок оценки: Up to 24 months]
• Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation [Срок оценки: Up to 24 months]
• Renal function as assessed by: eGFR per Full Age Spectrum (FAS) equation of Potell et al [Срок оценки: Up to 24 months]
• Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al [Срок оценки: Up to 24 Months]
• Proteinuria, as assessed by urinary protein:creatinine ratio (UPCR), as determined from single-voided urine specimens [Срок оценки: Up to 24 months]
• Slope of change in eGFR over time, as assessed by baseline-adjusted mean eGFR determinations at protocol-specified study visits [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Local Institution - 0042 — Birmingham
• Local Institution - 0041 — Los Angeles
• Local Institution - 0014 — Washington D.C.
• Local Institution - 0022 — Hollywood
• Local Institution - 0045 — Miami
• Local Institution - 0049 — Atlanta
• Local Institution - 0033 — Chicago
• Local Institution - 0017 — Baltimore
• … и ещё 7 центров

Франция · 6 центров

• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes
• Bordeaux University Hospital - Pellegrin-Pediatrics — Bordeaux
• Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique — Bron
• Hopital De La Timone — Marseille
• Hopital Necker — Paris
• Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo — Paris

Германия · 4 центра

• Universitaetsklinikum Essen — Essen
• Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung — Cologne
• Local Institution - 0011 — Hamburg
• Local Institution - 0026 — Heidelberg

Италия · 3 центра

• IRCCS Istituto Giannina Gaslini — Genoa
• Local Institution - 0030 — Milan
• Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale — Torino

Испания · 3 центра

• Local Institution - 0001 — Barcelona
• Local Institution - 0012 — Rivas-Vaciamadrid
• Local Institution - 0003 — Seville

Аргентина · 2 центра

• Hospital Italiano de Buenos Aires — ABB
• Local Institution - 0062 — Buenos Aires

Великобритания · 2 центра

• Local Institution - 0008 — Manchester
• Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team — Nottingham

Бельгия · 1 центр

• UZ Gent-Paediatric Nephrology and Rheumatology Department — Ghent

Нидерланды · 1 центр

• Emma Children (AMC) — Amsterdam

Норвегия · 1 центр

• Local Institution - 0061 — Oslo

Идентификаторы

NCT: NCT04877288 · IM103-402 · 2022-501677-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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