drugset / Trial / NCT04311632

A Dose Escalation Study in de Novo Renal Transplantation

NCT04311632

Phase 2 Completed 13 enrolled ITB-Med LLC
RandomizedSequentialOpen-labelBasic science

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.

Timeline

Start
2021-05-26
Primary completion
2023-10-03
Completion
2023-10-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic
Subject Siplizumab Monoclonal antibody
Background Mycophenolate Mofetil Small molecule
Background Tacrolimus Small molecule

Indications

No indication recorded.