Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
Lead Sponsor:
Bayer
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. A commo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06522997
Start Date
August 8 2024
End Date
March 17 2026
Last Update
November 5 2025
Active Locations (154)
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1
Nephrology Consultants, LLC
Huntsville, Alabama, United States, 35805-4104
2
Balboa Research SMO+ - Chula Vista - West
Chula Vista, California, United States, 91910
3
Balboa Research SMO+ - La Mesa
La Mesa, California, United States, 91942
4
California Kidney Specialists - San Dimas
San Dimas, California, United States, 91773