NCT04311632

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: ITB-Med LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	TCD601	Investigational Product
DRUG	Tacrolimus (TAC)	Standard of Care Concomitant Immunosuppression
DRUG	Corticosteroids (CS)	Standard of Care Concomitant Immunosuppression
DRUG	Mycophenolate Mofetil (MMF)	Standard of Care Concomitant Immunosuppression
DRUG	ATG	Standard of Care induction therapy in solid organ transplantation

Timeline

• Start date: 2021-05-26
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2020-03-17
• Last updated: 2025-02-27
• Results posted: 2025-02-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study