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(22267) A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of finerenone versus placebo, in addition to standard of care, in participants with chronic kidney disease and type 1 diabetes

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-503024-27-00
Acronym
22267
Enrollment
105
Registered
2023-10-12
Start date
2024-02-27
Completion date
2025-09-15
Last updated
2025-09-25

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

Conditions

Chronic kidney disease associated with type 1 diabetes mellitus

Brief summary

Change in UACR from baseline (ratio to baseline) over 6 months

Detailed description

Number of participants with TEAEs, TESAEs and Hyperkalaemia (AESI)

Interventions

DRUGFinerenone
DRUGplacebo equal to test product except active substance

Sponsors

Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in UACR from baseline (ratio to baseline) over 6 months

Secondary

MeasureTime frame
Number of participants with TEAEs, TESAEs and Hyperkalaemia (AESI)

Countries

Denmark, Germany, Italy, Spain

Outcome results

None listed

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