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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension and Chronic Kidney Disease (CKD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CinCor Pharma, Inc.
• Collaborator: Parexel

Criteria

Inclusion Criteria:

• Has a mean seated SBP ≥ 140 mmHg.

• Has a prior diagnosis of mild-to-severe CKD, defined as eGFR (based on the Chronic Kidney Disease Epidemiology [CKD-EPI] equation) of 25 to 75 mL/min/1.73 m2, inclusive, presumed to be diabetic nephropathy or hypertensive nephrosclerosis.

• Has a UACR ≥ 200 mg/g (≥ 22.6 mg/mmol).

• Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose.

• If taking a sodium-glucose cotransporter-2 (SGLT2) inhibitor at Screening, the regimen must be stable for a period of at least 8 weeks before Screening and be expected to remain at a stable dose over the study period.

• Is willing to be compliant with the contraception and reproduction restrictions of the study.

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) >45 kg/m2.

• 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 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 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.

• 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.