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New hope for rare kidney disease? trial tests imlifidase

NCT ID NCT05679401

Disease control Sponsor: Hansa Biopharma AB 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 imlifidase for people with severe Goodpasture disease, a rare condition where the immune system attacks the kidneys and lungs. The trial compared imlifidase plus standard care to standard care alone in 50 adults with poor kidney function. The goal was to see if imlifidase could improve kidney function at 6 months. However, the study was terminated early.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

50 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 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 years and older

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: 1. Anti-GBM antibodies constituting an indication for PLEX as judged by the Investigator 2. Haematuria on dipstick and/or urinary sediment 3. eGFR(MDRD) \<20 mL/min/1.73 m\^2 4. Patients aged ≥18 years 5. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol Exclusion Criteria: 1. Diagnosis of anti-GBM disease more than 14 days prior to randomisation 2. Anuria during the last 24-hour 3. Any constituent of SoC given more than 10 days prior to randomisation 4. IVIg within 4 weeks before randomisation 5. History or presence of any medical condition or disease which, in the opinion of the investigator, may place the patient at unacceptable risk, or jeopardise the purpose of the study 6. Patients previously randomised in the study 7. Unsuitable to participate in the trial for any other reason in the opinion of the investigator 8. Pregnancy or breast feeding 9. Contraception: 1. Men who are not vasectomised or abstinent or with a partner (of child-bearing potential) not willing to use one of the highly effective contraceptives listed below from screening to 6 months following discontinuation of CYC 2. Men who are not willing to refrain from donating sperm from screening to 6 months following discontinuation of CYC 3. Men who are not willing to use a condom during any form of sexual intercourse, regardless of a partner being of child-bearing potential from screening to 6 months following discontinuation of CYC 4. Women of child-bearing potential not willing or not able to use at least one highly effective contraceptive method from screening to 12 months following discontinuation of CYC. In the context of this trial, a highly effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: * combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/transdermal) * progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable) * intrauterine device (IUD) * intrauterine hormone-releasing system (IUS) * bilateral tubal occlusion * vasectomised partner * true abstinence: When this is in line with the preferred and usual lifestyle of the patient. \[Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\] 10. Previous imlifidase treatment or known hypersensitivity to any of the excipients

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Conditions

The condition(s) this trial relates to.

anti-glomerular basement membrane disease Rapidly progressive glomerulonephritis with pulmonary hemorrhage

As listed by the trial registrant

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

Anti-glomerular basement membrane antibody disease Anti-glomerular basement membrane disease Good pasture syndrome Goodpasture syndrome

Contacts and locations

Locations

  • ASST degli Spedali Civili di Brescia - SC Nefrologia

    Brescia, 25123, Italy

  • Aarhus University Hospital, Renal Medicine and Clinical Medicine

    Aarhus N, Central Jutland, 8200, Denmark

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Bordeaux, Hôpital Pellegrin, Service nephrologie, transplantation, dialyse, aphereses

    Bordeaux, New Aquitaine, 33076 cedex, France

  • CHU Grenoble Alpes - Michallon Hospital, Nephrology, Hemodialysis, Apheresis and Kidney Transplantation

    Grenoble, Auvergne-Rhône-Alpes, 38043, France

  • CHU Lille. Nephrology, dialysis transplantation

    Lille, Haus-de-France, 59037, France

  • CHU de Nantes, Hôtel-Dieu, Le service de néphrologie et immunologie clinique

    Nantes, Pays de la Loire Region, 44000, France

  • CHU de Rouen, Department of Nephrology,Transplantation, and Hemodialysis

    Bois-Guillaume, Normandy, 76130, France

  • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Dept. of Vasculitis

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Carl-Gustav-Carus University Hospital, Medizinische Klinik III, Nephrologie

    Dresden, Saxony, 01307, Germany

  • Charité Department of Nephrology and Intensive Care

    Berlin, 10117, Germany

  • Department of Renal Medicine, Cork University Hospital

    Cork, T12 DC4A, Ireland

  • Hammersmith Hospital, Renal medicine and centre for inflammatory diseases

    London, W12 0HS, United Kingdom

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hôpital Rangueil, CHU de Toulouse, Department of Nephrology and Organ transplantation

    Toulouse, Occitanie, 31059, France

  • IRCCS Policlinico San Martino University Hospital, Department of Internal Medicine, Division of Nephrology

    Genova, Genova-Liguria, 16132, Italy

  • IRCCS S. Orsola - Malpighi University Hospital - Nephrology, Dialysis and Transplantation Unit (pav 15)

    Bologna, 40138, Italy

  • John Hopkins Medical Institution

    Baltimore, Maryland, 21287, United States

  • Karolinska University Hospital

    Huddinge, 14186, Sweden

  • LMU Klinikum, Medical Clinic IV / Department of Nephrology

    Munich, Bavaria, 81377, Germany

  • Leiden University Medical Center, Department of Nephrology

    Leiden, South Holland, 2333, Netherlands

  • Linköping University Hospital

    Linköping, 58185, Sweden

  • Manchester University Hospitals NHS Foundation Trust

    Manchester, M13 9WL, United Kingdom

  • Med Uni Graz / LKH-UNIV Klinikum Graz, Klinische Abteilung fuer Nephrologie

    Graz, Stiermark, 8036, Austria

  • Medical University Innsbruck, Dept of Internal Medicine IV (Nephrology and Hypertension)

    Innsbruck, Tyrol, 6020, Austria

  • Medical University of Vienna, Dept of Medicine III, Division of Nephrology and dialysis

    Vienna, 1090, Austria

  • Nouvel Hôpital Civil (University Hospital of Strasbourg)

    Strasbourg, Grand Est, 67091 Cedex, France

  • Odense University Hospital, Medical Nephrology, Department Y

    Odense, Region Syddanmark, 5000, Denmark

  • Radboudumc

    Nijmegen, 6525 GA, Netherlands

  • Rigshospitalet, Department of Nephrology

    Copenhagen, 2100, Denmark

  • Royal Infirmary of Edinburgh, Department of Renal Medicine

    Edinburgh, EH16 4SA, United Kingdom

  • Skåne University Hospital, Department of Nephrology

    Lund, 22185, Sweden

  • Tenon Hospital, Renal intensive care unit

    Paris, Île-de-France Region, 75020, France

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201, United States

  • UCLA Medical Center Plaza

    Los Angeles, California, 90024, United States

  • UNC Kidney Center/Division of Nephrology & Hypertension

    Chapel Hill, North Carolina, 27599-7155, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uniklinik Koeln-Klinik II fuer Innere Medizin

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Uniklinik RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Universitaetsklinikum Erlangen - Medizinische Klinik 4

    Erlangen, 91054, Germany

  • University College London, Royal Free Hospital, Department of Renal Medicine

    London, NW3 2QG, United Kingdom

  • University Hospital Hamburg-Eppendorf, III Department of Medicine and Nephrology

    Hamburg, 20246, Germany

  • University Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • University Hospital of Marseille, Nephrology - Renal transplantation service

    Marseille, Bouches-du-Rhône, 13385, France

  • University Medical Center Groningen, Division of Nephrology

    Groningen, 9713GZ, Netherlands

  • University of Minnesota Health Clinical Research Unit

    Minneapolis, Minnesota, 55455, United States

  • Uppsala University Hospital, Department of Medical Sciences, Renal Medicine

    Uppsala, 751 85, Sweden

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 12808, Czechia

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