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A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601(Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients

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A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601(Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2025

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At a glance

  • Drugs Siplizumab (Primary) ; Antithymocyte globulin; Corticosteroids; Mycophenolate mofetil; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors ITBMed Biopharmaceuticals

    • Most Recent Events

    • 10 Apr 2024 Given protocol has been amended as above-1) Status has been changed from recruiting to completed.2) Number of treatment arms has been changed from 5 to 3.3) Actual patient number has been changed to 13.
    • 10 Apr 2024 Status changed from recruiting to completed.
    • 18 Oct 2023 Planned End Date changed from 1 Nov 2023 to 1 Mar 2026.

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