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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

StatusRecruiting
PhasePhase 3
Started2021-07-21
View on ClinicalTrials.gov ↗

Amendment history

2026-08-28
Study Status, Contacts/Locations v29
Study sites38 entries, revised
LocalInstituto Institutionde -Trasplantes 0062y Alta Complejidad
2026-06-22
Study Status, Contacts/Locations, IPDSharing v28
Study sites38 entries, revised
LocalHospital InstitutionItaliano -de 0060Buenos Aires
2026-02-02
Study Status, Contacts/Locations v27
Study sitesdetails revised at 1 of 38 sites
2026-01-16
Study Status, Contacts/Locations v26
Study sites38 entries, revised
LocalUniversitaetsklinikum InstitutionKoeln-Klinik und Poliklinik für Kinder- 0010und Jugendmedizin, Abteilung für Pädia
2025-11-07
Study Status, Contacts/Locations v25
Completion date2033-12-30→2034-06-30
Study sitescontacts updated at 1 of 38 sites
Show 24 earlier versions
2025-10-08
Study Identification, Study Status v24
Primary completion date2030-12-30→2032-12-30
Completion date2031-12-30→2033-12-30
2025-09-09
Study Status, Contacts/Locations v23
Study sites37→38
2025-06-24
Study Status, Contacts/Locations v22
Study sites37 entries, revised
LocalIRCCS InstitutionIstituto Giannina Gaslini Queen's Medical Centre, Nottingham University Hospitals-Children's 0059 LocalClinical InstitutionResearch - 0009Team
2025-04-04
Study Status, References v21
Primary completion date2026-05-25→2030-12-30
2025-02-03
Study Status, Contacts/Locations v20
Study sites35→37
2025-01-03
Study Status, Contacts/Locations, References v19
Study sites34→35
2024-10-25
Study Status, Outcome Measures, References v18
Completion date2028-01-07→2031-12-30
Secondary endpointsdetails revised at 1 of 33 entries
2024-07-31
Study Status, Contacts/Locations v17
Study sites34 entries, revised
LocalUniversitaetsklinikum Institution - 0057Essen
2024-07-03
Study Status, Contacts/Locations, References v16
Study sitesdetails revised at 2 of 34 sites
2024-05-29
Study Status, Contacts/Locations, References v15
Study sites31→34
2024-04-22
Study Status, Contacts/Locations v14
Study sites31 entries, revised
LocalOspedale InstitutionRegina Margherita-S.C 0036Nefrologia, Dialisi e Trapianto Renale
2024-03-27
Study Status, Contacts/Locations v13
Study sites31 entries, revised
LocalUZ InstitutionGent-Paediatric -Nephrology 0047and Rheumatology Department
2024-01-04
Study Status, Contacts/Locations, References v12
Study sites30→31
2023-11-02
Study Status, Contacts/Locations v11
Study sites19→30
2023-03-16
Study Status, Contacts/Locations v10
Study sites19 entries, revised
Local Institution - 0010
2023-03-14
Study Status, Contacts/Locations v9
Study sites16→19
2023-02-06
Study Status, Contacts/Locations, References v8
Study sites15→16
2022-10-24
Study Status, Contacts/Locations v7
Study sites15 entries, revised
Local Institution - 0011 Local Institution - 0008
2022-10-11
Study Status, Contacts/Locations v6
Study sites15 entries, revised
Local Institution - 0015
2022-09-13
Study Status, Contacts/Locations v5
Study sites14→15
2022-08-22
Study Status, Contacts/Locations v4
Study sites14 entries, revised
Local Institution - 0026
2022-08-12
Study Status, Contacts/Locations v3
Study sites14 entries, revised
Local Institution - 0047 Local Institution - 0001
2022-07-05
Study Status, Outcome Measures, Eligibility v2
Eligibility criteria+118 characters
[...] il (EC-MPS/MPA), with or without daily corticosteroids for ≥1 calendar30 monthsdays prior to randomization Clinically stable renal function dur [...] or 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 [...]
Secondary endpoints32 to 33 entries
Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al
2022-03-22
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-08-11→2026-05-25
Completion date2027-12-02→2028-01-07
Start dateestimated 2021-05-07→confirmed 2021-07-21
Eligibility criteria-119 characters
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Male and female adolescents 12 to less t [...]
Study sitesdetails revised at 14 of 14 sites
2021-05-06
Original filing
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.
Trial Details
NCT Number NCT04877288
Lead Sponsor Bristol-Myers Squibb
Conditions Renal Allograft Recipients
Enrollment 102 participants
Start Date 2021-07-21
Primary Completion 2032-12-30 (estimated)
Study Completion 2034-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-31