Trial Profile

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 Feb 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

29 Jan 2025 Status changed from active, no longer recruiting to completed.
18 Jul 2024 Planned End Date changed from 1 Aug 2025 to 1 Jul 2025.
18 Jul 2024 Planned primary completion date changed from 1 Aug 2025 to 1 Jul 2025.

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