A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease

Exclusion Criteria

• • Have a documented diagnosis of type 1 diabetes.
• • Are not willing or not able to discontinue a mineralocorticoid receptor antagonist (MRA) or a potassium sparing diuretic as part of an existing antihypertensive regimen.
• • Have a single occurrence of mean seated SBP >180 mmHg or DBP >110 mmHg during the Screening Period.
• • Has a body mass index (BMI) >50 kg/m^2.
• • Has documented bilateral clinically relevant renal artery stenosis of ≥70%.
• • Has had dialysis for acute kidney injury/acute renal failure within 12 weeks prior to the Screening Period or has a planned dialysis or kidney transplantation during the course of the study.
• • Has known documented chronic heart failure New York Heart Association Class III or Class IV and/or hospitalization for heart failure within 6 months of Screening.
• • Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months of Screening.
• • Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease.
• • Has planned any major cardiac surgery during the study or had major cardiac surgery within 6 months of Screening.
• • Has had a prior solid organ transplant or cell transplant.
• • Has a known hypersensitivity to CIN-107 or drugs of the same class
• • Has received immunotherapy for treatment of CKD within 6 months of Screening.
• • Has any clinically relevant medical or surgical conditions including unstable conditions and/or conditions requiring regular transfusion or treatment with systemic immunosuppressants, including corticosteroids.
• • Serum potassium <3.5 mEq/L or >5.0 mEq/L
• • Serum sodium <135 mEq/L
• • Serum aspartate aminotransferase or alanine aminotransferase >3 × upper limit of normal (ULN); or Total bilirubin >2 × ULN, unless due to Gilbert’s syndrome.
• • GFR is < 25 or > 75 mL/min/1.73 m2
• • Has uncontrolled diabetes with glycosylated hemoglobin >10.5%.
• • Is positive for Human immunodeficiency disease (HIV) antibody, hepatitis B surface antigen, or hepatitis C virus Ribonucleic acid (RNA).
• • Has typical consumption of >14 alcoholic drinks weekly.