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A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT06365437•ITB-Med LLC

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Karolinska University Hospital

Stockholm, Huddinge, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital

Malmo, Sweden

Key Dates

Start Date

June 6, 2021

Primary Completion Date

December 11, 2024

Completion Date

December 11, 2024

Last Updated

March 12, 2026

Enrollment

ACTUAL participants

Conditions

Kidney Transplantation

Interventions

TCD601

BIOLOGICAL

Tacrolimus (TAC)

DRUG

Corticosteroids (CS)

DRUG

Mycophenolate Mofetil (MMF)

DRUG

ATG

DRUG

Parathyroidectomy After Kidney Transplantation

NCT07415421

HyperparathyroidismKidney Transplantation Recipients

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RECRUITINGPHASE4

Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

NCT06958796

CytomegalovirusOrgan Transplant+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Parathyroidectomy After Kidney Transplantation

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