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A 12-month Randomized, Multiple Dose, Open-label, Study Evaluating Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) and Efficacy of an Anti-CD40 Monoclonal Antibody, CFZ533, in Combination With Mycophenolate Mofetil (MMF) and Corticosteroids (CS), With and Without Tacrolimus (Tac), in de Novo Renal Transplant Recipients

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Trial Profile

A 12-month Randomized, Multiple Dose, Open-label, Study Evaluating Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) and Efficacy of an Anti-CD40 Monoclonal Antibody, CFZ533, in Combination With Mycophenolate Mofetil (MMF) and Corticosteroids (CS), With and Without Tacrolimus (Tac), in de Novo Renal Transplant Recipients

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 22 Oct 2021

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At a glance

  • Drugs Iscalimab (Primary) ; Iscalimab (Primary) ; Basiliximab; Corticosteroids; Corticosteroids; Mycophenolic acid; Mycophenolic acid; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept; Therapeutic Use
  • Sponsors Novartis

    • Most Recent Events

    • 01 Sep 2021 Results presented at the 20th Congress of the European Society for Organ Transplantation
    • 03 Jun 2020 Results of RNA-seq profiling of whole blood samples from the study presented at the 2020 American Transplant Congress.
    • 06 Jun 2019 According to a Novartis media release, data were presented at at the American College of Transplantation Conference (ATC) 2019.

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