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New hope for kidney transplant patients: safer rejection prevention?

NCT ID NCT06365437

Disease control Sponsor: ITB-Med LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called TCD601 (siplizumab) in 33 kidney transplant patients to see if it could safely prevent organ rejection. The drug was compared to a standard treatment (ATG). The trial was stopped early, so we have limited information, but the goal was to find a gentler option for transplant recipients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TCD601 (siplizumab)
What this could lead to
If it works, this could point toward a safer way to prevent organ rejection after kidney transplant, reducing side effects compared to current treatments.
What could go wrong
This is an early, small Phase 2 trial that was terminated, so results are limited. The drug may not prove safer or more effective than standard therapy, and risks include infection and rejection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplantation

Contacts and locations

Locations

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, 08907, Spain

  • Innsbruck Medical University

    Innsbruck, A-6020, Austria

  • Karolinska University Hospital

    Stockholm, Huddinge, 14157, Sweden

  • Sahlgrenska University Hospital

    Gothenburg, 41345, Sweden

  • Skåne University Hospital

    Malmö, 20502, Sweden

  • University of Vienna

    Vienna, 1090, Austria

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