At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
TCD601 +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating TCD601, Tacrolimus (TAC), and 3 other interventions for Kidney Transplantation. Completed, enrolled 13 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartMay 2021
Primary CompletionOct 2023
TodayJul 2026
First PostedMar 17, 2020
Enrollment StartMay 26, 2021
Primary CompletionOct 3, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.3 years ago
Interventions
TCD601biological
Investigational Product
Tacrolimus (TAC)drug
Standard of Care Concomitant Immunosuppression
Corticosteroids (CS)drug
Standard of Care Concomitant Immunosuppression
Mycophenolate Mofetil (MMF)drug
Standard of Care Concomitant Immunosuppression
ATGdrug
Standard of Care induction therapy in solid organ transplantation