Last updated 13 days ago
A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
700 patients around the world
Available in Argentina
Bayer
7Research sites
700Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participant must be ≥18 years of age.EGFR (Chronic Kidney Disease Epidemiology Collaboration formula) should be ≥20 and ≤75 mL/min /1.73 m^2 at Screening. Note: One re-assessment of EGFR based on central laboratory values is allowed during the Screening period.UACR should be ≥200 mg/g and <3500 mg/g as determined by the geometric mean (as calculated by the central laboratory) of 3 morning void urine specimens obtained at 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.
- Systolic blood pressure (SBP) should not be less than 100 mmHg at Visit 2 (baseline).Patients with a tendency for clinically relevant orthostatic hypotension at Screening and Visit 2 (baseline) as judged by the investigator.SBP should not be greater than or equal to 160 mmHg, unless treated with greater than or equal to 3 blood pressure lowering medications, at Screening or at Visit 2 (baseline).History of secondary hypertension other than CKD.Hepatic impairment corresponding to Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST or ALT greater than 3x ULN or total bilirubin greater than 2x ULN) at Screening.Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and any other kidney disease requiring immunosuppressive therapy within 6 months prior to Screening.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Instituto Cardiovascular San Luis
CEDIC Centro de Investigación Clínica - CABA, Buenos Aires
Centro Especialidades Médicas SRL (CEMEDIC)
Fundación Centro de Salud e Investigaciones Médicas (CESIM)
Centro Médico Privado San Vicente Diabetes - Córdoba
StudyALPINE 1
SponsorBayer
Conditions
Chronic kidney disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06522997
