CompletedPhase 2

A Study of TCD601 in de Novo Renal Transplant Recipients

United States76 participantsStarted 2023-12-28

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key 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 ABO compatable, non-HLA identical living related donor Key Exclusion Criteria: * 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

What they're measuring

The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2

Timeframe: 12 months

Trial details

NCT IDNCT05669001

SponsorITB-Med LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-10

View on ClinicalTrials.gov More Renal Transplantation trials