chronic kidney disease
Conditions
Interventions
BAY2327949 60 mg (2 tablets of 30 mg, orally) once daily for 28 days.
Placebo: Matching placebo orally once daily for 28 days.
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - A clinical diagnosis of chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) * 25 mL/min/1.73 m^2 but * 60 mL/min/1.73 m^2 (estimated using the CKD-EPI [Epidemiology Collaboration] equation) as assessed during Visit 1, and albuminuria (as measured by urine albumin-to- creatinine ratio [UACR]) in the range of * 30 but * 3000 mg/g, based on the first assessment for Visit 1. - CKD with a clinical cause of either T2D or hypertension: -- if T2D is the clinical cause, history of type 2 diabetes mellitus as defined by the American Diabetes Association (on treatment with glucose- lowering medications and/or insulin) for at least 2 years before randomization and on a stable therapy with sodium-glucose transport protein 2 (SGLT2) inhibitor for at least 3 months before randomization; -- if hypertension is the clinical cause, patients must have a history of systolic blood pressure (BP) values * 140 mmHg and/or diastolic BP values * 90 mmHg, and on hypertension medication for at least 5 years before randomization. - Stable treatment with either angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) at the maximal tolerated labelled daily dose and otherwise stable antihypertensive treatment both for at least 3 months before randomization. If taking an SGLT2 inhibitor, the participant must be on stable treatment for at least 3 months before randomization without any planned changes in dosing during the study period. All treatments must be expected to remain stable over the study period without any planned dose adjustments. - Body mass index within the range of 18-38 kg/m^2 as evaluated for Visit 1. - Male participants must agree to use barrier contraception (condoms). Female participants must be of non-child-bearing potential.
Exclusion criteria
Exclusion criteria: - Known non-diabetic or non-hypertensive renal disease (e.g. autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, bilateral clinically relevant renal artery stenosis, lupus nephritis, or ANCA-associated vasculitis, or any other secondary glomerulonephritis) - Clinical diagnoses of heart failure and persistent symptoms (NYHA class III * IV), or hospitalization for worsening heart failure in the last 3 months prior to signing the ICF - Uncontrolled hypertension indicated by > 160 mmHg systolic BP or *100 mmHg diastolic BP at Visit 1 or Visit 2 or at any unscheduled visit before randomization - History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma) ; stroke, transient ischemic cerebral attack, acute coronary syndrome in the last 3 months prior to signing the ICF. - Dialysis for acute renal failure within the previous 6 months prior to signing the ICF - Renal allograft in place or a scheduled kidney transplant within the next 18 weeks from signing the ICF (being on a waiting list does not exclude the participant) - Hepatic insufficiency classified as Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST/ALT >3x ULN) - Active malignancy. Previous malignancies are allowed if there is a 5-year remission- and treatment-free time before signing the ICF - Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study. - For participants without diabetes: receiving off-label treatment with an SGLT2 inhibitor - Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to signing ICF - Combination use of an ACE inhibitor and ARB within 3 months prior to signing ICF - Concomitant therapy with drugs that strongly induce or inhibit CYP3A4 (cytochrome P-450 3A4), or that are inhibitors of P-gp (P-glucoprotein). - Planned change of concomitant medications or dose adjustments during participation in this study - Participation in another clinical study with treatment with another investigational product 90 days prior to signing ICF - HbA1c > 11% at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in UACR at end of treatment (Visit 6) versus baseline (Visit 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of treatment- emergent adverse events (TEAEs). | — |
Countries
Netherlands
Outcome results
None listed