Evaluation of Conversion from Calcineurin Inhibitor- to Belatacept-based Immunosuppression in Adolescent Renal Transplant Recipients and their Compliance with Immunosuppressive Medications

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000237-12-DE

Enrollment

120

Registered

2020-12-08

Start date

2021-05-04

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Renal Allografts MedDRA version: 21.0 Level: PT Classification code 10038533 Term: Renal transplant System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: Belatacept Product Code: BMS-224818 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: BELATACEPT CAS Number: 749867-37-6 Current Sponsor code: BM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and females between 12 to less than 18 years of age - Documented EBV seropositivity prior to transplant and randomization - Receiving a stable regimen of a CNI with a mycophenolate with or without concomitant corticosteroids for > 1 calendar month prior to randomization - Stable renal function 12 weeks prior to screening based upon investigator assessment and protocol-defined criteria for eGFR and proteinuria Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - No treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment. - No history of biopsy confirmed antibody mediated rejection or Banff Grade IIA or higher acute cellular rejection with the current transplant

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of patient and functional graft survival of adolescent renal allograft recipients converted from CNI to belatacept-based immunosuppression at least 6 months post-transplant as compared to those of recipients remaining on CNI at 24 months post-randomization.;Secondary Objective: Evaluation of the impact of conversion from CNI to belatacept on the following key outcomes: ? participant and graft survival ? BPAR ? renal function ? adherence to immunosuppressive medications ? hypertension and antihypertensive management ? metabolic parameters, including those for diabetes mellitus and hyperlipidemia ? de novo anti-HLA donor specific antibody formation ? immunogenicity of belatacept ? belatacept whole blood trough (C0) concentrations ? pharmacodynamic efficacy ? safety and tolerability ? Tanner staging ? Linear Growth (height);Primary end point(s): Proportion of participants who survive with a functional graft with an eGFR > 30 mL/min/1.73 m2 (updated Schwartz formula);Timepoint(s) of evaluation of this end point: 24 months post-randomization	—

Measure

Time frame

Main Objective: Evaluation of patient and functional graft survival of adolescent renal allograft recipients converted from CNI to belatacept-based immunosuppression at least 6 months post-transplant as compared to those of recipients remaining on CNI at 24 months post-randomization.;Secondary Objective: Evaluation of the impact of conversion from CNI to belatacept on the following key outcomes: ? participant and graft survival ? BPAR ? renal function ? adherence to immunosuppressive medications ? hypertension and antihypertensive management ? metabolic parameters, including those for diabetes mellitus and hyperlipidemia ? de novo anti-HLA donor specific antibody formation ? immunogenicity of belatacept ? belatacept whole blood trough (C0) concentrations ? pharmacodynamic efficacy ? safety and tolerability ? Tanner staging ? Linear Growth (height);Primary end point(s): Proportion of participants who survive with a functional graft with an eGFR > 30 mL/min/1.73 m2 (updated Schwartz formula);Timepoint(s) of evaluation of this end point: 24 months post-randomization

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Secondary

Measure	Time frame
Secondary end point(s): 1/ Participant and graft survival 2/ Acute rejections: Incidence and severity of clinically suspected, BPAR 3/ Renal function: Mean values over time and mean change from baseline level of renal function 4/ Adherence to immunosuppressive medication 5/ Hypertension and antihypertensive management 6/ Metabolic parameters (including those for diabetes mellitus and hyperlipidemia) 7/ Donor Specific antibodies 8/ Immunogenicity of belatacept 9/ Belatacept whole blood trough (C0) concentrations 10/ Pharmacodynamic Efficacy (Percent CD86 receptor occupancy) 11/ Safety and tolerability 12/ Tanner Staging 13/ Linear Growth (height) ;Timepoint(s) of evaluation of this end point: 1/ 6, 12 and 24 months post-randomization 2/ 3, 6, 12 and 24 months post-randomization 3/ Slopes from baseline and from Month 3 through Months 6, 12, 18 and 24 post-randomization 4/ Summaries over time 5/ at baseline and 6, 12, 18 and 24 months post-randomization 6/ from baseline over time 7/ at baseline and 6, 12 and 24 months post-randomization 8/ at baseline and 6, 12 and 24 months post-randomization 9/ at baseline and 6, 12 and 24 months post-randomization 10/ at baseline and 6, 12 and 24 months post-randomization 11/ Summaries over time 12/ at baseline, 12 and 24 months post-randomization 13/ at baseline, 12 and 24 months post-randomization	—

Measure

Time frame

Secondary end point(s): 1/ Participant and graft survival 2/ Acute rejections: Incidence and severity of clinically suspected, BPAR 3/ Renal function: Mean values over time and mean change from baseline level of renal function 4/ Adherence to immunosuppressive medication 5/ Hypertension and antihypertensive management 6/ Metabolic parameters (including those for diabetes mellitus and hyperlipidemia) 7/ Donor Specific antibodies 8/ Immunogenicity of belatacept 9/ Belatacept whole blood trough (C0) concentrations 10/ Pharmacodynamic Efficacy (Percent CD86 receptor occupancy) 11/ Safety and tolerability 12/ Tanner Staging 13/ Linear Growth (height) ;Timepoint(s) of evaluation of this end point: 1/ 6, 12 and 24 months post-randomization 2/ 3, 6, 12 and 24 months post-randomization 3/ Slopes from baseline and from Month 3 through Months 6, 12, 18 and 24 post-randomization 4/ Summaries over time 5/ at baseline and 6, 12, 18 and 24 months post-randomization 6/ from baseline over time 7/ at baseline and 6, 12 and 24 months post-randomization 8/ at baseline and 6, 12 and 24 months post-randomization 9/ at baseline and 6, 12 and 24 months post-randomization 10/ at baseline and 6, 12 and 24 months post-randomization 11/ Summaries over time 12/ at baseline, 12 and 24 months post-randomization 13/ at baseline, 12 and 24 months post-randomization

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Countries

Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026