A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease (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 - ALPINE-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076672

Enrollment

1400

Registered

2024-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: N18- Chronic kidney disease (CKD)

Interventions

Intervention1: BAY 3283142 Coated immediate-release tablet: 2.5 mg or 5.0 mg or 10.0 mg or 15.0 mg, or 20.0 mg, once daily, orally up to 16 weeks Control Intervention1: Placebo to BAY 3283142 Coated i

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants aged >=18 years, male or female (not of child-bearing potential) 2. CKD patients with eGFR more than or equal 20 and less than or 75 ml/min/1.73 mÂ² and UACR more than or equal 200 mg/g and less than 3000 mg/g at screening visit

Exclusion criteria

Exclusion criteria: 1. Hepatic impairment (AST or ALT more than 3x the ULN; or total bilirubin more than 2x ULN) at Screening 2. Stroke, TIA, ACS, or hospitalization for worsening heart failure in the last 3 months prior to screening - Treatment with the highest tolerated labeled dose of either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless such treatment is either not tolerated or contraindicated. Treatment dose must be stable dose for at least 4 weeks before Screening with no planned change of the therapy during the study - If the participant receives any of the following treatments it should be stable for 4 weeks prior to Screening: sodium-glucose co-transporter-2 (SGLT2) inhibitor, finerenone, diuretics, endothelin-receptor antagonists, or glucagon-like peptide (GLP) receptor agonist 3. SBP less than 100 mmHg at Visit 2 (baseline)

Design outcomes

Primary

Measure	Time frame
The primary efficacy objective is to estimate and assess a dose-response relationship in the primary endpoint of mean change in UACR from baseline after 16 weeks of treatment with BAY 3283142 compared with placebo in addition to SoC in CKD patientsTimepoint: Up to 24 weeks	—

Secondary

Measure	Time frame
Efficacy - â?¢ To investigate the course of eGFR over time â?¢ To investigate the mean change from baseline in UACR over time. Safety - To investigate the overall safety and tolerability of treatment with BAY 3283142 compared with placebo in addition to SoCTimepoint: Up to 24 weeks	—

Countries

Argentina, Belgium, China, Greece, India, Italy, Japan, Portugal, Republic of Korea, Singapore, Slovakia, Spain, Sweden, United Kingdom, United States of America

Contacts

Public ContactAleksandr Poskonnyi

Bayer Pharmaceuticals Private Limited

aleksandr.poskonnyi@bayer.com919967617940

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026