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New drug aims to kickstart kidneys after transplant

NCT ID NCT05907096

Disease control Sponsor: argenx 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called ARGX-117 in people who get a kidney from a deceased donor and are at risk for delayed graft function (when the kidney takes time to start working). About 103 participants will receive either the drug or a placebo by IV. The goal is to see if the drug improves kidney function and reduces the need for dialysis after transplant.

What this could mean

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

Active substance
ARGX-117 (a biologic drug given intravenously)
What this could lead to
If it works, this could help transplanted kidneys start working sooner, reducing the need for dialysis after surgery.
What could go wrong
This is an early phase 2 trial with only 103 participants, so results may not apply to everyone. The drug may not improve kidney function or could cause side effects.

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

103 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Jul 2026

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 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: * Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years * Agree to use contraceptive measures consistent with local regulations * Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months * Are recipients of de novo or second-time, single kidney transplant from a deceased donor, either DCD (donation after cardiac/circulatory death) or DBD ( (donation after brain death) * Are ABO compatible with donor allograft, except for type A2 donor to type B recipient kidneys * Have a negative cross match * Have received pretransplant vaccinations for: Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae, or are willing to receive the vaccinations approximately 3 to 4 months posttransplant Exclusion Criteria: * Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting * Any known history of complement deficiency * Evidence of peritonitis in participants on peritoneal dialysis * Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant * High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator * Clinically significant comorbidity, recent major surgery (within 3 months of screening), history of any treatment nonadherence, or intention to have surgery during the study other than kidney transplantation; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk * Clinically significant active bacterial, viral, or fungal infection * History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 5 years or more before first study drug administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer * History of current alcohol, drug, or medication abuse as assessed by the investigator * Pregnant or lactating state or intention to become pregnant during the study The full list of criteria can be found in the protocol.

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Conditions

The condition(s) this trial relates to.

Delayed Graft Function end stage renal failure

As listed by the trial registrant

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

Delayed graft function

Contacts and locations

Locations

  • Akademiska sjukhuset

    Uppsala, 75185, Sweden

  • Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

    Vienna, 1090, Austria

  • Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor

    Créteil, 94000, France

  • Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades

    Paris, 75015, France

  • Azienda Ospedale Universita Padova

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola

    Bologna, 40138, Italy

  • CHRU de Tours - Hopital Bretonneau

    Tours, 37000, France

  • CHU Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • CHU Grenoble Alpes - Hopital Michallon

    La Tronche, 38700, France

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, 31400, France

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral

    Lisbon, 1069-099, Portugal

  • Centro Hospitalar Universitario de Santo Antonio

    Porto, 4099-001, Portugal

  • Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz

    Carnaxide, 2790-134, Portugal

  • Centro Hospitalar e Universitario de Coimbra

    Coimbra, 3004-561, Brazil

  • Columbia University

    New York, New York, 10032, United States

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

  • Erie County Medical Center

    Buffalo, New York, 14215, United States

  • Fundacio Puigvert

    Barcelona, 08025, Spain

  • Hospital Geral de Fortaleza

    Fortaleza, 60156-290, Brazil

  • Hospital Universitari Doctor Peset

    Valencia, 46017, Spain

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona, 08916, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de las Nieves - Hospital General

    Granada, 18014, Spain

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

    São Paulo, 05403-000, Brazil

  • Hospital de Base

    São Jose Do Rio Preto, 15090-000, Brazil

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hôpital Maisonneuve-Rosemont - Centre de recherche

    Montreal, H1T 2M4, Canada

  • McGill University Health Centre - Royal Victoria Hospital

    Montreal, H4A 3J1, Canada

  • Monash Health - Monash Medical Centre

    Clayton, 3168, Australia

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102, Australia

  • Providence Health Care - St. Pauls Hospital

    Vancouver, V6Z 1Y6, Canada

  • Royal Adelaide Hospital

    Adelaide, SA 5000, Australia

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345, Sweden

  • Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer

    Porto Alegre, 90020-090, Brazil

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck

    Innsbruck, 6020, Austria

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • University of Illinois (UI) Health - Outpatient Care Center

    Chicago, Illinois, 60612, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 10267, United States

  • Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre

    Vancouver, V5Z 1M9, Canada

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