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

Korábbi kezelés

• 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 had a prior solid organ transplant or cell transplant.
• 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.

Más betegség

• Have a documented diagnosis of type 1 diabetes.
• 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 a known hypersensitivity to CIN-107 or drugs of the same class
• Is positive for Human immunodeficiency disease (HIV) antibody, hepatitis B surface antigen, or hepatitis C virus Ribonucleic acid (RNA).

Laborértékek

• 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.
• 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%.

Egyéb

• 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 typical consumption of >14 alcoholic drinks weekly.

• Has a mean seated SBP ≥ 140 mmHg.
• Has a prior diagnosis of mild-to-severe CKD.
• Has an elevated UACR.
• Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose.