A study to learn about how well BAY 3401016 works in adults with Alport syndrome
Key facts
- Where
- Alcázar de San Juan, Barcelona, Madrid és Sevilla, SpanyolországSee the 5 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- Hospital General La Mancha CentroAlcázar de San Juan, SpanyolországNo longer taking part
- Fundació PuigvertBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bayer AG
- Trial code
- EU 2024-516471-33-00
- Record updated
- 2026. október 23.
- Original description
Assess the effect of BAY 3401016 on albuminuria in participants with Alport syndromeRead full original descriptionShow less
(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
Assess the effect of BAY 3401016 on albuminuria in participants with Alport syndrome
Inclusion: 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.
Exclusion: 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; Systolic blood pressure above 140 mmHg; Diastolic blood pressure above 90 mmHg.