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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04877288
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Renal Allograft Recipients

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Belatacept — BIOLOGICAL
    Specified dose on specified days
  • Tacrolimus — DRUG
    Specified dose on specified days
  • Cyclosporine A — DRUG
    Specified dose on specified days
  • Mycophenolate Mofetil — DRUG
    Specified dose on specified days
  • Enteric Coated Mycophenolate Sodium — DRUG
    Specified dose on specified days
  • Corticosteroids — DRUG
    Specified dose on Specified days

Study Details

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.

Key Dates

Start date
Jul 21, 2021
Status verified
Feb 2026
Primary completion
Dec 30, 2032
Completion
Jun 30, 2034

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap
    Conversion followed by tapering and discontinuation of the calcineurin inhibitor (CNI)
  • Active Comparator: Arm 2: Continue calcineurin inhibitor-based regimen

Primary Outcome Measure

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 ]

Central Contacts

  • BMS Study Connect Contact Center www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (15)

FacilityCityStateZIPSite coordinators
Local Institution - 0042BirminghamAlabama35233-
Local Institution - 0041Los AngelesCalifornia90095-
Local Institution - 0014Washington D.C.District of Columbia20010-
Local Institution - 0022HollywoodFlorida33021-
Local Institution - 0045MiamiFlorida33136-
Local Institution - 0049AtlantaGeorgia30322-
Local Institution - 0033ChicagoIllinois60611-
Local Institution - 0017BaltimoreMaryland21287-
Local Institution - 0044BostonMassachusetts02115-
Local Institution - 0043St LouisMissouri63110-
Local Institution - 0024DurhamNorth Carolina27710-
Local Institution - 0025CincinnatiOhio45229-
Local Institution - 0048ClevelandOhio44124-
Local Institution - 0052PortlandOregon97239-
Local Institution - 0038SeattleWashington98105-

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By research site
Local Institution - 0042· Birmingham, ALLocal Institution - 0041· Los Angeles, CALocal Institution - 0014· Washington D.C., DCLocal Institution - 0022· Hollywood, FLLocal Institution - 0045· Miami, FLLocal Institution - 0049· Atlanta, GA