(22040 ALPINE 1) A Phase 2b dose-finding, randomized, placebo-controlled, double-blind study to evaluate efficacy and safety of BAY 3283142 on top of standard of care in reducing albuminuria in patients with chronic kidney disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505755-40-00

Acronym

22040

Enrollment

557

Registered

2024-08-06

Start date

2024-08-16

Completion date

2025-11-14

Last updated

2025-12-15

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

Conditions

Chronic kidney disease

Brief summary

Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)

Detailed description

Change from baseline over time (Visits 5, 6 and 7) in estimated glomerular filtration rate (eGFR), Change from baseline over time (Visits 5, 6 and 7) in the logarithm of UACR, Number of subjects with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to permanent discontinuation of study intervention

Interventions

DRUGBAY 3283142

DRUGBAY 3283142 PLACEBO

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)	—

Secondary

Measure	Time frame
Change from baseline over time (Visits 5, 6 and 7) in estimated glomerular filtration rate (eGFR), Change from baseline over time (Visits 5, 6 and 7) in the logarithm of UACR, Number of subjects with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to permanent discontinuation of study intervention	—

Countries

Belgium, Greece, Italy, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

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