Active — Not RecruitingPhase 2

A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)

United States, South Korea18 participantsStarted 2022-12-14

Plain-language summary

The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients

Who can participate

Age range

18 Years – 65 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 any study assessment is performed * Male or female patients ≥ 18 to 65 years of age * Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor Key Exclusion Criteria: * Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol * A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix * Recipient with anti-HLA donor-specific antibody (DSA)

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

The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance

Timeframe: 24 months

Trial details

NCT IDNCT04803058

SponsorITB-Med LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Kidney Transplantation trials

Who can participate

Age range

18 Years – 65 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.