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New hope for kidney transplant patients: experimental drug tegoprubart aims to replace tacrolimus

NCT ID NCT06126380

Disease control Sponsor: Eledon Pharmaceuticals 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new drug called tegoprubart (AT-1501) to see if it is safe and effective for preventing kidney transplant rejection over several years. About 132 people who have already received a kidney transplant will receive either tegoprubart or the standard drug tacrolimus, along with other immunosuppressants. Researchers will monitor side effects and how well the transplanted kidney works.

What this could mean

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

Active substance
Tegoprubart (AT-1501) plus standard immunosuppressants (mycophenolate mofetil and corticosteroids)
What this could lead to
If successful, tegoprubart could offer a safer, more tolerable alternative to tacrolimus for preventing kidney transplant rejection.
What could go wrong
This is an early-phase, open-label extension study with no placebo group, so results are preliminary. Long-term risks and benefits are still unknown.

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

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

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 100 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: * Successfully completed qualifying Parent study, where entry into the OLE was offered; * Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent; * Agree not to participate in another interventional study while on treatment; * If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6. * If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug. Exclusion Criteria: * Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator; * Met any of the stopping criteria or discontinued study drug in the Parent study; * Pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease transplant rejection

As listed by the trial registrant

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

Kidney transplant rejection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Augusta University

    Augusta, Georgia, 30912, United States

  • CHU Grenoble-Alpes - Hopital Nord Michallon

    Grenoble, 38700, France

  • CHU de Toulouse - Hopital de Rangueil

    Toulouse, 31400, France

  • Centre Hospitalier Universitaire Dupuytren

    Limoges, 07042, France

  • Charite Universitatsmedizin Berlin

    Berlin, Germany

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Fiona Stanley Hospital

    Perth, Western Australia, 6150, Australia

  • Fundação Oswaldo Ramos - Hospital do Rim

    São Paulo, 04038-002, Brazil

  • Groupe Hospitalier Pellegrin

    Bordeaux, France

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital Clinical de Barcelona

    Barcelona, 08036, Spain

  • Hospital Germans Trias i Pujol

    Barcelona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, 08907, Spain

  • Hospital das Clínicas da Faculdade de Medicina de São Paulo

    São Paulo, 05403-010, Brazil

  • Hospital del Mar - Parc de Salut Mar

    Barcelona, 08003, Spain

  • Jacobs Medical Center at UC San Diego Health

    San Diego, California, 92037, United States

  • John Hopkins University

    Baltimore, Maryland, 21287, United States

  • Keck School of Medicine of USC

    Los Angeles, California, 90033, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55907, United States

  • McGill University Health Care Centre

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • New York University Langone Health - Tisch Hospital

    New York, New York, 10016, United States

  • Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

    Oxford, OX3 9DU, United Kingdom

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z IY6, Canada

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Tulane Medical Center

    New Orleans, Louisiana, 70112, United States

  • UT Southwestern

    Dallas, Texas, 75235, United States

  • University of California Los Angeles

    Los Angeles, California, 90024, United States

  • University of California, Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California, Irvine Medical Center

    Orange, California, 92868, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh Medical Center

    Harrisburg, Pennsylvania, 17104, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.