Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04877288
Other study ID # IM103-402
Secondary ID 2018-000237-12
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 21, 2021
Est. completion date January 7, 2028

Study information

Verified date May 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 immunosuppressive medications.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Belatacept
Specified dose on specified days
Drug:
Tacrolimus
Specified dose on specified days
Cyclosporine A
Specified dose on specified days
Mycophenolate Mofetil
Specified dose on specified days
Enteric Coated Mycophenolate Sodium
Specified dose on specified days
Corticosteroids
Specified dose on Specified days

See more »

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Participant and graft survival: Proportion of participants who survive with a functioning graft 6 and 12 months
Secondary Participant and graft survival: Proportion of participants who survive 6, 12, and 24 months
Secondary Participant and graft survival: Proportion of participants who experience death-censored graft loss 6, 12, and 24 months
Secondary Acute rejection: Incidence of clinically suspected biopsy-proven acute rejection (BPAR) 3, 6, 12, and 24 months
Secondary Acute rejection: Severity of clinically suspected, biopsy confirmed rejection as determined by locally and centrally reviewed histopathology 3, 6, 12, and 24 months
Secondary Renal function as assessed by: Serum creatinine concentration Up to 24 months
Secondary Renal function as assessed by: Estimated GFR (eGFR per updated Schwartz combined equation) Up to 24 months
Secondary Renal function as assessed by: eGFR per updated bedside Schwartz approximating equation Up to 24 months
Secondary Renal function as assessed by: eGFR per Full Age Spectrum (FAS) equation of Potell et al Up to 24 months
Secondary Renal function as assessed by: eGFR per age and sex-dependent equation of Pierce et al Up to 24 Months
Secondary Proteinuria, as assessed by urinary protein:creatinine ratio (UPCR), as determined from single-voided urine specimens Up to 24 months
Secondary Slope of change in eGFR over time, as assessed by baseline-adjusted mean eGFR determinations at protocol-specified study visits Up to 24 months
Secondary 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 up to 24 months
Secondary Adherence to immunosuppressive medications, as assessed by: Variations in pre-dose concentrations of calcineurin inhibitor in whole blood Up to 24 months
Secondary 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 Up to 24 months
Secondary Adherence to immunosuppressive medications, as assessed by: Monitoring of compliance with monthly belatacept infusions Up to 24 months
Secondary Adherence to immunosuppressive medications, as assessed by: Periodic review of parents' and patients' perceived barriers to adherence to the prescribed immunosuppressive medications regimen Up to 24 months
Secondary Mean blood pressure over time Up to 24 months
Secondary Mean blood pressure changes from baseline over time Up to 24 months
Secondary Intensity of antihypertensive drug therapy, defined as the total number of medications used to maintain BP control Up to 24 months
Secondary Monitoring of safety laboratory parameters over time: Mean fasting lipid profiles Up to 24 months
Secondary Monitoring of safety laboratory parameters over time: Fasting blood glucose concentrations Up to 24 months
Secondary Monitoring of safety laboratory parameters over time: Hemoglobin A1c concentrations Up to 24 months
Secondary 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 6, 12, and 24 months
Secondary Immunogenicity of belatacept as determined by the proportion of participants with detectable serum anti-belatacept antibodies 6, 12, and 24 months
Secondary Belatacept pre-dose (C0) serum concentrations Up to 24 months
Secondary Mean percent belatacept CD86 receptor occupancy Baseline
Secondary Post-randomization changes from baseline percent belatacept CD86 receptor occupancy 6, 12, and 24 months
Secondary Safety and tolerability of belatacept following conversion: Incidence of Adverse Events (AEs) up to 24 months
Secondary Safety and tolerability of belatacept following conversion: Incidence of Serious Adverse Events (SAEs) Up to 24 months
Secondary Safety and tolerability of belatacept following conversion: Incidence of laboratory marked abnormalities Up to 24 months
Secondary 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 Up to 24 months
Secondary Linear growth (height) Up to 24 months
See also
  Status Clinical Trial Phase
Completed NCT00895583 - Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients Phase 4
Completed NCT00470665 - Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients Phase 3