NCT04877288|RecruitingPhase 3DMCFDA Drug

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

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

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

IM103-4022022-501677-39

Study Type

interventional

Target

102

Locations

10 countries

Sites

Timeline

RegisteredMay 2021

StartedJul 2021

CompletionJun 2034

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

102

participants targeted

Target at P25-P50 for phase_3

Timeline

100mo left

Started Jul 2021

Longer than P75 for phase_3

Geographic Reach

10 countries

38 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13 years study duration

Study Progress37%

Jul 2021Jun 2034

First Submitted

Initial submission to the registry

May 3, 2021

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

July 21, 2021

Completed

11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2032

Expected

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2034

Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

11.5 years

First QC Date

May 3, 2021

Last Update Submit

February 2, 2026

Conditions

Renal Allograft Recipients

Keywords

Acute rejectionBelataceptCalcineurin inhibitors (cyclosporine, tacrolimus)ConversionDonor-specific antibodieseGFRImmunosuppressive regimenAdolescent kidney transplant recipients

Outcome Measures

Primary Outcomes (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
24 months

Secondary Outcomes (33)

Participant and graft survival: Proportion of participants who survive with a functioning graft
6, 12 and 24 months
Participant and graft survival: Proportion of participants who survive
6, 12, and 24 months
Participant and graft survival: Proportion of participants who experience death-censored graft loss
6, 12, and 24 months
Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR)
3, 6, 12, and 24 months
Acute rejection: Severity of clinically suspected, biopsy confirmed rejection as determined by locally and centrally reviewed histopathology
3, 6, 12, and 24 months
+28 more secondary outcomes

Study Arms (2)

Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap

EXPERIMENTAL

Conversion followed by tapering and discontinuation of the calcineurin inhibitor (CNI)

Biological: BelataceptDrug: TacrolimusDrug: Cyclosporine ADrug: Mycophenolate MofetilDrug: Enteric Coated Mycophenolate SodiumDrug: Corticosteroids

Arm 2: Continue calcineurin inhibitor-based regimen

ACTIVE COMPARATOR

Drug: TacrolimusDrug: Cyclosporine ADrug: Mycophenolate MofetilDrug: Enteric Coated Mycophenolate SodiumDrug: Corticosteroids

Interventions

BelataceptBIOLOGICAL

Specified dose on specified days

Also known as: Nulojix

Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap

TacrolimusDRUG

Specified dose on specified days