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New drug cocktail aims to improve kidney transplant success

NCT ID NCT05669001

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a new combination of drugs—siplizumab, belatacept, and mycophenolic acid—in 76 people who just received a kidney transplant. The goal was to see if this combo is safer and works better than the usual immunosuppression therapy. Researchers measured side effects and kidney function over 12 months.

What this could mean

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

Active substance
siplizumab (TCD601) combined with belatacept and mycophenolic acid
What this could lead to
If successful, this could offer a new way to prevent organ rejection with fewer side effects than current standard treatments.
What could go wrong
This is an early phase 2 trial with only 76 participants, so results may not apply to everyone. The combination therapy could still cause serious side effects or fail to improve outcomes.

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

76 people

The number who actually took part.

Started

Dec 2023

Finished

Apr 2026

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.

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 ABO compatable, non-HLA identical living related donor Key Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

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

Renal transplantation

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Inova Fairfax Hospital Medical Campus

    Falls Church, Virginia, 22042, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California San Francisco Medical Center

    San Francisco, California, 94143, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia Health

    Charlottesville, Virginia, 22903, United States

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