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New drug aims to slow kidney failure in rare genetic disease

NCT ID NCT07211685

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This study tests an experimental drug called BAY 3401016 in 60 adults aged 18 to 45 with Alport syndrome, a rare genetic condition that damages kidneys, hearing, and eyes. The drug works by blocking a protein thought to cause kidney injury, with the goal of slowing the loss of kidney function. Participants will receive either the drug or a placebo, and researchers will measure changes in urine protein levels over 24 weeks to see if the treatment helps.

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 60 people

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

Started

Nov 2025

Expected to finish

Nov 2027

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 45 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: * Participants must be 18 to 45 years of age inclusive * Participants with AS, either XLAS (male) or ARAS (male or female) * eGFR ≥ 45 mL/min/1.73m2 * UACR ≥ 500mg/g Exclusion Criteria: * Chronic kidney disease is different from AS * Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives * History or current existence of malignancy * Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids or urticaria * Participants with active skin disorders (e.g. atopic dermatitis, severe acne) * Systolic blood pressure above 140 mmHg * Diastolic blood pressure above 90 mmHg

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • All India Institute of Medical Sciences (AIIMS) - New Delhi

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte

    Paris, Île-de-France Region, 75015, France

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto

    Bologna, 40138, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia

    Brescia, 25123, Italy

  • CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation

    Brest, Brittany Region, 29200, France

  • Cardio Renal Institute

    Chubbuck, Idaho, 83202, United States

  • Center for Advanced Pediatrics - Nephrology

    Atlanta, Georgia, 30329, United States

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes

    Toulouse, Occitanie, 31400, France

  • Centre hospitalier universitaire de Québec (CHUQ) | Nephrology

    Québec, G1R 2J6, Canada

  • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

    Buenos Aires, C1431FWO, Argentina

  • Centro de Rehabilitacion Cardiovascular | San Luis, Argentina

    San Luis, D5700CGR, Argentina

  • Charité Mitte - Nephrologie und Internistische Intensivmedizin

    Berlin, 10117, Germany

  • Children's Hospital of Chongqing Medical University - Department of Nephrology

    Chongqing, Chongqing Municipality, 401122, China

  • Children's Hospital, Zhejiang University School of Medicine - Department of Nephrology

    Hangzhou, Zhejiang, 310052, China

  • Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A.

    Santa Fe, Santa Fe Province, S3000EPV, Argentina

  • Fakultní nemocnice Hradec Kralové - Nefrologická klinika

    Hradec Králové, Hradec Králové Region, 500 05, Czechia

  • Fundacio Puigvert | Nefrologia

    Barcelona, 8025, Spain

  • Hospital Británico

    Buenos Aires, C1280AEB, Argentina

  • Hospital General La Mancha Centro | Nefrologia

    Alcázar de San Juan, Ciudad Real, 13600, Spain

  • Hospital Universitari Vall D Hebron | Nefrologia

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department

    Madrid, 28040, Spain

  • Hospital Universitario Virgen Del Rocio S.L. | Nefrologia

    Seville, 41013, Spain

  • Hospital de Curry Cabral - Nephrology Department

    Lisbon, 1069-166, Portugal

  • Hospital de Torres Novas - Nephrology Department

    Torres Novas, Santarém District, 2350-399, Portugal

  • IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene

    Genova, 16147, Italy

  • Japanese RedCross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650, Japan

  • K.G. Hospital

    Coimbatore, Tamil Nadu, 641018, India

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • Lakeridge Health | Nephrology

    Whitby, Ontario, L1N 5T2, Canada

  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Mavani Research Center

    Ahmedabad, Gujarat, 380052, India

  • Montreal General Hospital | Nephrology

    Montreal, Quebec, H4A 3J1, Canada

  • Nephrology Clinic at The Kirklin Clinic of UAB Hospital

    Birmingham, Alabama, 35233, United States

  • Northern General Hospital | Sheffield Kidney Institute

    Sheffield, South Yorkshire, S5 7AU, United Kingdom

  • Ospedale Pediatrico Bambino Gesù - Nefrologia

    Roma, 00165, Italy

  • Peking University First Hospital - Department of Pediatrics

    Beijing, Beijing Municipality, 100000, China

  • Renal Disease Research Institute | Landry

    Dallas, Texas, 75246, United States

  • Royal Devon and Exeter Hospital | Renal Unit

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Free Hospital | Centre for Nephrology

    London, Greater London, NW3 2QG, United Kingdom

  • Saitama Prefectural Children's Medical Center

    Chuo-Ku, Tokyo, 330-8777, Japan

  • Seoul National University Bundang Hospital | Nephrology

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital | Nephrology

    Seoul, 03080, South Korea

  • St Joseph's Healthcare Hamilton | Cardiology

    Hamilton, Ontario, L8N 4A6, Canada

  • Sunderland Royal Hospital | Renal Unit

    Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

  • The First Affiliated Hospital, Sun Yat-sen University - Department of Pediatrics

    Guangzhou, Guangdong, 510080, China

  • The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)

    Kolkata, West Bengal, 700020, India

  • The Peggy and Harold Katz Family Drug Discovery Center - Nephrology

    Miami, Florida, 33136, United States

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Pediatric Nephrology and Immunology

    Wuhan, Hubei, 430205, China

  • Tufts Medical Center | Nephrology Department

    Boston, Massachusetts, 02111, United States

  • Unidade Local de Saude de Gaia/Espinho E.P.E Nephrology Department

    Vila Nova de Gaia, 4434-502, Portugal

  • Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Nefrologia

    Porto, 4200-319, Portugal

  • Universitaetsklinikum Erlangen - Medizinische Klinik 4, Nephrologie, Hypertensiologie

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Koeln - Klinik II fuer Innere Medizin - Nephrologie, Rheumatologie, Diabetologie, Innere Medizin

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsmedizin Goettingen (UMG) - Klinik fuer Nephrologie und Rheumatologie

    Göttingen, Lower Saxony, 37075, Germany

  • University Hospital | Nephrology

    London, Ontario, N6A 5A5, Canada

  • Uniwersytecki Szpital Kliniczny w Poznaniu - Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych

    Poznan, 60-355, Poland

  • Všeobecná fakultní nemocnice v Praze - Klinika nefrologie

    Prague, Prague, 128 08, Czechia

  • Wojskowy Instytut Medyczny Państwowy Instytut Badawczy - Centrum Wsparcia Badań Klinicznych

    Warsaw, 04-141, Poland

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