Home › Trials › NCT06522997

Investigating the effectiveness and safety of BAY3283142 for chronic kidney disease

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

Phase 2 Interventional Bayer · NCT06522997

This study is testing a new drug called BAY3283142 to see if it can help adults with chronic kidney disease lower the amount of protein in their urine while they continue their usual treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorBayer Industry-sponsored
Locations170 sites (Huntsville, Alabama and 169 other locations)
Trial IDNCT06522997 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic kidney disease, specifically those with an eGFR between 20 and 75 mL/min/1.73 m² and elevated urine albumin levels.

Not a fit: Patients with contraindications to ACE inhibitors or ARBs, or those with eGFR below 20 mL/min/1.73 m² may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and health outcomes for patients with chronic kidney disease.

How similar studies have performed: Other studies have explored treatments for chronic kidney disease, but the specific approach of BAY3283142 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Huntsville, Alabama and 169 other locations

+120 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.