Chronic Kidney Disease, Diabetic Kidney Disease

- 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.

- 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 [New York Heart Association] class III – IV), or hospitalization for worsening heart failure in the last 3 months prior to signing the informed consent form (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.