Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05432167
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 \<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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT05432167
Study Brief:
Protocol Section:
NCT05432167