(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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516471-33-00

Acronym

22419

Enrollment

Registered

2025-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alport Syndrome, Chronic kidney disease

Brief summary

Mean UACR ratio to baseline averaged over 16, 20 and 24 weeks of treatment

Detailed description

Number of participants with TEAEs and TESAEs

Interventions

DRUGBAY 3401016

DRUGPlacebo to BAY 3401016

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Mean UACR ratio to baseline averaged over 16, 20 and 24 weeks of treatment	—

Secondary

Measure	Time frame
Number of participants with TEAEs and TESAEs	—

Countries

Czechia, France, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026