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

Completed · Phase 2 · Has a placebo group

Conditions studied: Uncontrolled Hypertension, Chronic Kidney Diseases

In brief

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).

Key facts

Study ID: NCT05432167
Run by: AstraZeneca
People needed: 195
Starts: 2022-04-29
Expected to finish: 2024-05-02
Last updated by the study team: 2025-05-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Birmingham, Alabama, United States
Research Site — Huntsville, Alabama, United States
Research Site — Beverly Hills, California, United States
Research Site — Chula Vista, California, United States
Research Site — Fountain Valley, California, United States
Research Site — Granada Hills, California, United States
Research Site — Lancaster, California, United States
Research Site — Lincoln, California, United States
Research Site — Los Angeles, California, United States
Research Site — Lynwood, California, United States
Research Site — Northridge, California, United States
Research Site — Panorama City, California, United States
Research Site — Pomona, California, United States
Research Site — Rancho Cucamonga, California, United States
Research Site — Riverside, California, United States
Research Site — San Dimas, California, United States
Research Site — South Gate, California, United States
Research Site — Tarzana, California, United States
Research Site — Vacaville, California, United States
Research Site — Victorville, California, United States
Research Site — Arvada, Colorado, United States
Research Site — Littleton, Colorado, United States
Research Site — Hollywood, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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