a study to evaluate cin-107 for the treatment of patients with uncontrolled hypertension and chronic kidney disease

Conditions: Uncontrolled Hypertension; Chronic Kidney Diseases

Summary: this study will evaluate the efficacy and safety of cin-107 for the treatment of hypertension in patients with uncontrolled hypertension (uhtn) and chronic kidney disease (ckd).

this randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of cin-107 in patients with uhtn and ckd. approximately 200 patients will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy). the study will consist of the following 3 periods: * a screening period of up to 5 weeks; * a double-blind treatment period of 26 weeks; and * a follow-up period of 2 weeks. patients will complete the study in approximately 8 months.

Eligibility criteria:
inclusion criteria: * 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. 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 \ 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 \ 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.