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

Not Recruiting
18 - 70 years of age
Both
Phase 2

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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.

Eligibility

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

Study details

Kidney Transplantation

NCT06365437

ITB-Med LLC

5 February 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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