Wirksamkeit und Sicherheit von Selonsertib bei Patienten mit diabetischer Nierenerkrankung

Drug: Placebo
Drug: SEL

Key Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines. - eGFR value calculated by central laboratory utilizing samples collected during screening and prior to enrollment of = 20 mL/min/1.73 m^2 to < 60 mL/min/1.73 m^2 with albuminuria - eGFR and urine albumin to creatinine ratio (UACR) must meet criteria a, b, or c - a: eGFR (mL/min/1.73 m^2): = 45 to < 60; UACR (mg/g): = 600 - b: eGFR (mL/min/1.73 m^2): = 30 to < 45; UACR (mg/g): = 300 - c: eGFR (mL/min/1.73 m^2): = 20 to < 30; UACR (mg/g): = 150 - Treatment with either an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) - Individuals not receiving an ACEi or ARB may be enrolled if there is documented intolerance to ACEi and ARB - Individuals receiving less-than-maximal dose of an ACEi or ARB may be enrolled if there is a documented reason that the maximum labeled dose of ACEi and ARB could not be reached - Individuals already receiving sodium-glucose co-transporter-2 (SGLT-2) inhibitors must be on a stable dose for at least 2 weeks prior to enrollment - Mean systolic blood pressure (SBP) must be 50 kg/m^2 - UACR > 5000 mg/g on any measurement during screening - End stage renal disease (ESRD) (i.e., peritoneal dialysis, hemodialysis, or history of kidney transplantation) - Anticipated progression to ESRD (need for dialysis or receipt of kidney transplant) within 3 months after enrollment - Unstable CV disease - Pregnant or lactating females or planning to become pregnant or breastfeed during the study - Concurrent use of a mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to enrollment - Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Minimum age: 18 Years
Maximum age: 80 Years
Sex: All