2024-516471-33-00Active, not recruitingPhase 2
A study to learn about how well BAY 3401016 works in adults with Alport syndrome
(22419) A randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Oct 2026
Brief summary (registry, in English)
Assess the effect of BAY 3401016 on albuminuria in participants with Alport syndrome
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 15 Aug 2025
- Start date
- 19 Jan 2026
- Lead sponsor
- Bayer AG
- Diseases
- Chronic kidney disease
- EU CT number
- 2024-516471-33-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 31
- 26 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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), that, in the investigator’s judgment, could interfere with or confound the evaluation of local infusion/injection-site reactions to the study intervention.
Other
- Systolic blood pressure above 140 mmHg
- Diastolic blood pressure above 90 mmHg
Who the study is looking for
- 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
- Treatment with ACEi and/or ARB
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | Active, not recruiting |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Active, not recruiting |
| University Hospital Cologne AöR | Cologne | Germany | Active, not recruiting |
| Universitaetsklinikum Erlangen AöR | Erlangen | Germany | Active, not recruiting |
| Universitaetsmedizin Goettingen | Goettingen | Germany | Active, not recruiting |
| Hospital General La Mancha Centro | Alcázar de San Juan | Spain | Active, not recruiting |
| Fundació Puigvert | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Active, not recruiting |
| Centre Hospitalier Régional et Universitaire de Brest | Brest | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | Italy | Active, not recruiting |
| IRCCS Istituto Giannina Gaslini | Genoa | Italy | Active, not recruiting |
| Ospedale Pediatrico Bambino Gesù | Rome | Italy | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi | Lodz | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Active, not recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy | Warsaw | Poland | Active, not recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. | Lisbon | Portugal | Active, not recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. | Porto | Portugal | Active, not recruiting |
| Centro Hospitalar Do Medio Tejo E.P.E. | Torres Novas | Portugal | Active, not recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E | Vila Nova de Gaia | Portugal | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.