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

Sponsored by AstraZeneca

About this trial

Last updated a year ago

Study ID

CIN-107-123

Status

Active, not recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 130 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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).

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status