A Dose Escalation Study in de Novo Renal Transplantation
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
Sponsor: ITB-Med LLC
Listed as NCT04311632, this PHASE2 trial focuses on Kidney Transplantation and remains completed. Sponsored by ITB-Med LLC, it has been updated 14 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
14 versions recorded-
Mar 2025 — Present [monthly]
Completed PHASE2
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Sep 2024 — Mar 2025 [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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May 2024 — Jul 2024 [monthly]
Completed PHASE2
Status: Recruiting → Completed
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Mar 2024 — May 2024 [monthly]
Recruiting PHASE2
▶ Show 9 earlier versions
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Nov 2023 — Mar 2024 [monthly]
Recruiting PHASE2
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Sep 2023 — Nov 2023 [monthly]
Recruiting PHASE2
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Jun 2023 — Sep 2023 [monthly]
Recruiting PHASE2
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Nov 2022 — Jun 2023 [monthly]
Recruiting PHASE2
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Jul 2022 — Nov 2022 [monthly]
Recruiting PHASE2
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Sep 2021 — Jul 2022 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Mar 2021 — Sep 2021 [monthly]
Not Yet Recruiting PHASE2
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Jan 2021 — Mar 2021 [monthly]
Not Yet Recruiting PHASE2
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Apr 2020 — Jan 2021 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- ITB-Med LLC
For direct contact, visit the study record on ClinicalTrials.gov .