Clinical trial NCT06365437: A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Lead sponsor: ITB-Med LLC
Sponsor class: INDUSTRY
First posted: 2024-04-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
timeFrame: 12 months
measure: Measure Peak Plasma Concentration (Cmax) over time.
timeFrame: 12 months
measure: Measure the Area under the plasma concentration versus time curve (AUC).
timeFrame: 12 months
Secondary outcomes:
measure: Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time.
timeFrame: 12 months
measure: Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time.
timeFrame: 12 months
measure: Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation.
timeFrame: 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
city: Vienna
country: Austria
facility: University of Vienna
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Huddinge
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: ITB-Med LLC
name: Nick Hryciw, MA
role: STUDY_DIRECTOR
References: