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A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)

Trial Profile

A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Oct 2019

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At a glance

  • Drugs Iscalimab (Primary) ; Iscalimab (Primary) ; Mycophenolate mofetil; Mycophenolate mofetil; Prednisolone; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Therapeutic Use
  • Acronyms CIRRUS I
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 11 Jul 2019 Planned End Date changed from 9 Sep 2022 to 13 May 2025.
    • 11 Jul 2019 Planned primary completion date changed from 9 Sep 2022 to 12 May 2021.
    • 06 Jun 2019 According to an Novartis Media release, findings about whether calcineurin-free treatment with iscalimab preserves the quality of transplanted kidney grafts are to be confirmed based on this trial.
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