TerminatedPhase 2

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

Stopped: After enrolment was complete, and sufficient data was collected to fully characterize the highest dose cohort, study follow up was terminated by the sponsor for non-safety related reasons.

Austria, Spain, Sweden33 participantsStarted 2021-06-06

Plain-language 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.

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.

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

What they're measuring

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

Timeframe: 12 months

Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.

Timeframe: 12 months

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

Timeframe: 12 months

Trial details

NCT IDNCT06365437

SponsorITB-Med LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-11

Results submitted2026-01-13

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