Investigating the effectiveness and safety of BAY3283142 for chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness and safety of a new drug, BAY3283142, in treating chronic kidney disease (CKD) by reducing albumin levels in urine. Participants will receive either BAY3283142 or a placebo alongside their standard CKD treatment. The study will measure changes in the urine albumin-creatinine ratio to assess the drug's impact. Eligible participants include adults with specific kidney function and albuminuria levels.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be ≥18 years of age
* eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) ≥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 ≥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

Exclusion Criteria:

* Systolic blood pressure (SBP) \<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 ≥160 mmHg, unless treated with ≥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 \>3x ULN or total bilirubin \>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

Where it's running

• Nephrology Consultants, LLC
  Huntsville, Alabama, United States Recruiting
• Balboa Research SMO+ - Chula Vista - West
  Chula Vista, California, United States Recruiting
• Balboa Research SMO+ - La Mesa
  La Mesa, California, United States Recruiting
• California Kidney Specialists - San Dimas
  San Dimas, California, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting
• Nova Clinical Research - Blake Medical Center
  Bradenton, Florida, United States Recruiting

+120 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.