The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients. This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
418
Comparison with standard of care immunosuppression
Standard of care immunosupprevive regimen
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Aurora, Colorado, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Chicago, Illinois, United States
Proportion of patients with composite event (BPAR, Graft Loss or Death)
Cohorts 1 and 2-Proportion of patients with composite event (BPAR, Graft Loss or Death) over 12 months
Time frame: Month 12
Cohorts 1 and 2-Mean eGFR over 12 months
Renal function at Month 12
Time frame: Baseline to month 12
Cohorts 1 and 2-Cohorts 1 and 2-safety of CFZ533 regimens compared to a tacrolimus based regimen
Proportion of patients with AEs, SAEs, infections, malignancies, thromboembolic events, major adverse cardiovascular events, new onset diabetes mellitus (NODM).
Time frame: Baseline to month 12
Cohorts 1 and 2-Cohorts 1 and 2 - tolerability of CFZ533 regimens compared to a tacrolimus based regimen
Tolerability assessment by rate of premature discontinuation from study, premature discontinuation of study drug, dose interruption and dose adjustment
Time frame: Baseline to month 12
Cohorts 1 and 2-pharmacokinetics of CFZ533 during the 60 months treatment period and explore the dose-exposure relationship
Free CFZ533 plasma concentrations over time
Time frame: Baseline to month 60
Cohorts 1 and 2-immunogenicity of CFZ533 during the 60 months treatment period
Semi-quantitative analysis of anti-CFZ533 antibodies in plasma
Time frame: Baseline to month 60
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Novartis Investigative Site
Kansas City, Kansas, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
St Louis, Missouri, United States
...and 64 more locations