Renal Allograft RecipientsPhase 3NCT04877288
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 Phase 3 study testing Belatacept, Tacrolimus and Cyclosporine A in people with Renal Allograft Recipients, run by Bristol-Myers Squibb at 38 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Renal Allograft Recipients
- What is being tested?
- Belatacept, Tacrolimus and Cyclosporine A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 21 Jul 2021to 30 Jun 2034
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
38 sites in 10 countries
United States15 sites
- Withdrawn
Local Institution - 0049
Atlanta, Georgia, 30322
- Withdrawn
Local Institution - 0017
Baltimore, Maryland, 21287
- Withdrawn
Local Institution - 0042
Birmingham, Alabama, 35233
- Withdrawn
Local Institution - 0044
Boston, Massachusetts, 02115
- Withdrawn
Local Institution - 0033
Chicago, Illinois, 60611
- Withdrawn
Local Institution - 0025
Cincinnati, Ohio, 45229
- Withdrawn
Local Institution - 0048
Cleveland, Ohio, 44124
- Withdrawn
Local Institution - 0024
Durham, North Carolina, 27710
- Withdrawn
Local Institution - 0022
Hollywood, Florida, 33021
- Withdrawn
Local Institution - 0041
Los Angeles, California, 90095
- Withdrawn
Local Institution - 0045
Miami, Florida, 33136
- Withdrawn
Local Institution - 0052
Portland, Oregon, 97239
- Withdrawn
Local Institution - 0038
Seattle, Washington, 98105
- Withdrawn
Local Institution - 0043
St Louis, Missouri, 63110
- Withdrawn
Local Institution - 0014
Washington D.C., District of Columbia, 20010
France6 sites, 6 recruiting
- Recruiting
Bordeaux University Hospital - Pellegrin-Pediatrics
Bordeaux, 33076
Jerome Harambat, Site 0056, +33661986263
- Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique
Bron, 69677
Anne-Laure SELLIER-LECLERC, Site 0028, +33427856128
- Recruiting
Hopital De La Timone
Marseille, 13005
Florentine Garaix, Site 0054, +334 91 38 83 83
- Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, 44093
Gwenaelle Roussey, Site 0055, +33253482237
- Recruiting
Hopital Necker
Paris, 75015
Olivia Boyer, Site 0027, +33689031066
- Recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
Paris, 75019
Julien Hogan, Site 0029, 33638691391
Germany4 sites, 3 recruiting
- Recruiting
Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia
Cologne, 50937
Lutz Weber, Site 0010, 0049-173-5842620
- Recruiting
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45122
Lars Pape, Site 0057, +495115323283
- Completed
Local Institution - 0011
Hamburg, 20246
- Recruiting
Local Institution - 0026
Heidelberg, 69120
Site 0026
Italy3 sites, 2 recruiting
- Recruiting
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, 16147
ENRICO VERRINA, Site 0059, 003901056362630
- Withdrawn
Local Institution - 0030
Milan, 20122
- Recruiting
Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale
Torino, 10126
Licia Peruzzi, Site 0036, 0039 0113135365
Spain3 sites
- Completed
Local Institution - 0001
Barcelona, 08035
- Completed
Local Institution - 0012
Rivas-Vaciamadrid, 28523
- Completed
Local Institution - 0003
Seville, 41013
Argentina2 sites, 2 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
Paula Coccia, Site 0060, 5491140727138
- Recruiting
Instituto de Trasplantes y Alta Complejidad
Buenos Aires, 1425
Laila Rodríguez Rilo, Site 0062, +5491139877200
United Kingdom2 sites, 1 recruiting
- Completed
Local Institution - 0008
Manchester, M13 9WL
- Recruiting
Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team
Nottingham, NG7 2UH
Jon Jin Kim, Site 0009, 01159249924
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent-Paediatric Nephrology and Rheumatology Department
Ghent, 9000
Agnieszka Prytula, Site 0047, +3293320368
Netherlands1 site, 1 recruiting
- Recruiting
Emma Children (AMC)
Amsterdam, 1105 AZ
Antonia Bouts, Site 0015, 0031610061279
About this study
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
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.
- Conditions
- Renal Allograft Recipients
- Being tested
- Belatacept, Tacrolimus, Cyclosporine A, Mycophenolate Mofetil, Enteric Coated Mycophenolate Sodium
- Keywords
- Acute rejection, Belatacept, Calcineurin inhibitors (cyclosporine, tacrolimus), Conversion, Donor-specific antibodies, eGFR, Immunosuppressive regimen, Adolescent kidney transplant recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptBiological
Also called Nulojix
Specified dose on specified days
TacrolimusDrug
Specified dose on specified days
Cyclosporine ADrug
Specified dose on specified days
Specified dose on specified days
Enteric Coated Mycophenolate SodiumDrug
Specified dose on specified days
CorticosteroidsDrug
Specified dose on Specified days
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Belatacept; Drug: Tacrolimus; Drug: Cyclosporine A; Drug: Mycophenolate Mofetil; Drug: Enteric Coated Mycophenolate Sodium; Drug: Corticosteroids |
| Arm 2: Continue calcineurin inhibitor-based regimen | Active comparator | Not described Receives: Drug: Tacrolimus; Drug: Cyclosporine A; Drug: Mycophenolate Mofetil; Drug: Enteric Coated Mycophenolate Sodium; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (33)
Participant and graft survival: Proportion of participants who survive with a functioning graft
Measured: 6, 12 and 24 months
Participant and graft survival: Proportion of participants who survive
Measured: 6, 12, and 24 months
Participant and graft survival: Proportion of participants who experience death-censored graft loss
Measured: 6, 12, and 24 months
Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR)
Measured: 3, 6, 12, and 24 months
Acute rejection: Severity of clinically suspected, biopsy confirmed rejection as determined by locally and centrally reviewed histopathology
Measured: 3, 6, 12, and 24 months
Renal function as assessed by: Serum creatinine concentration
Measured: Up to 24 months
Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation)
Measured: Up to 24 months
Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation
Measured: Up to 24 months
Renal function as assessed by: eGFR per Full Age Spectrum (FAS) equation of Potell et al
Measured: Up to 24 months
Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al
Measured: Up to 24 Months
Proteinuria, as assessed by urinary protein:creatinine ratio (UPCR), as determined from single-voided urine specimens
Measured: Up to 24 months
Slope of change in eGFR over time, as assessed by baseline-adjusted mean eGFR determinations at protocol-specified study visits
Measured: Up to 24 months
Adherence to immunosuppressive medications as assessed by variation in calcineurin inhibitor pre-dose whole blood concentrations by summaries over time of monitored adherence to orally administered immunosuppressive medications
Measured: up to 24 months
Adherence to immunosuppressive medications, as assessed by: Variations in pre-dose concentrations of calcineurin inhibitor in whole blood
Measured: Up to 24 months
Adherence to immunosuppressive medications, as assessed by: 7-day recall of missed and late doses of each orally administered immuno-suppressive medication at protocol-specified study visits
Measured: Up to 24 months
Adherence to immunosuppressive medications, as assessed by: Monitoring of compliance with monthly belatacept infusions
Measured: Up to 24 months
Adherence to immunosuppressive medications, as assessed by: Periodic review of parents' and patients' perceived barriers to adherence to the prescribed immunosuppressive medications regimen
Measured: Up to 24 months
Mean blood pressure over time
Measured: Up to 24 months
Mean blood pressure changes from baseline over time
Measured: Up to 24 months
Intensity of antihypertensive drug therapy, defined as the total number of medications used to maintain BP control
Measured: Up to 24 months
Monitoring of safety laboratory parameters over time: Mean fasting lipid profiles
Measured: Up to 24 months
Monitoring of safety laboratory parameters over time: Fasting blood glucose concentrations
Measured: Up to 24 months
Monitoring of safety laboratory parameters over time: Hemoglobin A1c concentrations
Measured: Up to 24 months
Donor Specific antibodies (DSA): Proportion of participants with pre-existing anti-human leukocyte antigen (HLA) DSAs at baseline and with de novo anti-HLA DSA post-randomization
Measured: 6, 12, and 24 months
Immunogenicity of belatacept as determined by the proportion of participants with detectable serum anti-belatacept antibodies
Measured: 6, 12, and 24 months
Belatacept pre-dose (C0) serum concentrations
Measured: Up to 24 months
Mean percent belatacept CD86 receptor occupancy
Measured: Baseline
Post-randomization changes from baseline percent belatacept CD86 receptor occupancy
Measured: 6, 12, and 24 months
Safety and tolerability of belatacept following conversion: Incidence of Adverse Events (AEs)
Measured: up to 24 months
Safety and tolerability of belatacept following conversion: Incidence of Serious Adverse Events (SAEs)
Measured: Up to 24 months
Safety and tolerability of belatacept following conversion: Incidence of laboratory marked abnormalities
Measured: Up to 24 months
Proportion of participants within each stage of the Tanner staging scale
The Tanner scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult
Measured: Up to 24 months
Linear growth (height)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start21 Jul 2021
- Primary completion30 Dec 2032 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Allograft RecipientsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877288
- Sponsor's protocol ID
- IM103-402
- Other IDs
- 2022-501677-39
- Status last verified
- Aug 2026
- First submitted
- 3 May 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html