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A Dose Escalation Study in de Novo Renal Transplantation

NCT04311632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-02-27

Study results available
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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

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

Sponsors & Collaborators

  • ITB-Med LLC

    lead INDUSTRY

Principal Investigators

  • Nick Hryciw, MA · ITB-Med LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2023-10-03
Completion
2023-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311632 on ClinicalTrials.gov