Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Belatacept, Tacrolimus, Cyclosporine A, Mycophenolate Mofetil.
- Who it may be relevant to
- Registry conditions: Renal Allograft Recipients. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Belgium, France, Germany +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- 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 (12)
- Participant and graft survival: Proportion of participants who survive with a functioning graft [Time frame: 6, 12 and 24 months]
- Participant and graft survival: Proportion of participants who survive [Time frame: 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]
- Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR) [Time frame: 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]
- Renal function as assessed by: Serum creatinine concentration [Time frame: Up to 24 months]
- Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation) [Time frame: Up to 24 months]
- Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation [Time frame: 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]
- Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al [Time frame: 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- 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
- … and 7 more centers
France · 6 centers
- 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
Germany · 4 centers
- Universitaetsklinikum Essen — Essen
- Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung — Cologne
- Local Institution - 0011 — Hamburg
- Local Institution - 0026 — Heidelberg
Italy · 3 centers
- IRCCS Istituto Giannina Gaslini — Genoa
- Local Institution - 0030 — Milan
- Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale — Torino
Spain · 3 centers
- Local Institution - 0001 — Barcelona
- Local Institution - 0012 — Rivas-Vaciamadrid
- Local Institution - 0003 — Seville
Argentina · 2 centers
- Hospital Italiano de Buenos Aires — ABB
- Local Institution - 0062 — Buenos Aires
United Kingdom · 2 centers
- Local Institution - 0008 — Manchester
- Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team — Nottingham
Belgium · 1 center
- UZ Gent-Paediatric Nephrology and Rheumatology Department — Ghent
Netherlands · 1 center
- Emma Children (AMC) — Amsterdam
Norway · 1 center
- Local Institution - 0061 — Oslo
Identifiers
NCT: NCT04877288 · IM103-402 · 2022-501677-39