A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation

Phase 2TerminatedNCT06365437

ITB-Med LLC33 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Kidney Transplantation

Interventions

TCD601BIOLOGICAL

Investigational Product

Tacrolimus (TAC)DRUG

Standard of Care Concomitant Immunosuppression

Corticosteroids (CS)DRUG

Standard of Care Concomitant Immunosuppression

Mycophenolate Mofetil (MMF)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able to understand the study requirements and provide written informed consent before and study assessment is performed. * Male or female patients ≥ 18 to 70 years of age. * Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor. * Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours. Exclusion Criteria: * Multiple-organ transplant recipients * Subjects who have received a kidney allograft previously * Recipient of a kidney from an HLA identical living related donor * Recipient of a kidney from a donor after cardiac death * Subjects at high immunological risk for rejection

Locations (7)

Innsbruck Medical University

Innsbruck, Austria

University of Vienna

Vienna, Austria

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

Outcomes

Primary Outcomes

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.

Time frame: 12 months

Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.

The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.

Time frame: 12 months

Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).

The AUC from time zero to the last measurable concentration sampling time.

Time frame: 12 months

Secondary Outcomes

The Incidence of Allograft Rejection at 12 Months Post-Transplant

Time frame: 12 months

To Assess Renal Function Over Time

Time frame: 12 months

Data from ClinicalTrials.gov

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