CompletedPhase 2

A Dose Escalation Study in de Novo Renal Transplantation

United States13 participantsStarted 2021-05-26

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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

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 unrelated, or non-HLA identical living related donor. * Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours. Key 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months

Measure Peak Plasma Concentration (Cmax) Over Time.

Timeframe: 12 months

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

Timeframe: 12 months

Trial details

NCT IDNCT04311632

SponsorITB-Med LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-03

Results submitted2025-02-06

View on ClinicalTrials.gov More Kidney Transplantation trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

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