Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria

Criteria the registry did not label

• Major Inclusion Criteria:
• At Screening, UACR of 200-5000 mg/g, inclusive, in first morning urine void
• At Screening, eGFRs of ≥30 mL/min/1.73 m2
• At Screening, AOBP SBP of 135-180 mmHg, inclusive
• On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
• At Screening, body mass index (BMI) of \>18 kg/m2
  • Major Exclusion Criteria:
• Subjects with known hypersensitivity to lorundrostat or any of its respective excipients
• Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (subjects beginning dapagliflozin only)
• At Screening, serum potassium \>5.0 mmol/L
• History of clinically significant hyponatremia within 1 year prior to Screening
• Use of epithelial sodium channel (ENaC) inhibitors or Mineralocorticoid receptor antagonist (MRAs), including, but not limited to amiloride, triamterene, spironolactone, eplerenone, finerenone, from 4 weeks prior to the Screening Visit and during study participation. With the exception of MRAs in primary aldosteronism
• Medical history of kidney disease related to autoimmune diseases (lupus, anti-neutrophil cytoplasmic antibody \[ANCA\] vasculitis), multiple myeloma or other known paraproteins, infiltrative diseases of the kidney, obstructive nephropathy, cystic kidney diseases, and renal transplantation
• Medical history of advanced liver disease, including cirrhosis
• Medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy
• Diabetes mellitus with a glycosylated hemoglobin (HbA1c) \>10% (\>86 mmol/mol) at Screening