Status:
COMPLETED
A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Uncontrolled Hypertension
Chronic Kidney Diseases
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief 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).
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2024
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT05432167
Start Date
April 29 2022
End Date
May 2 2024
Last Update
May 20 2025
Active Locations (71)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Birmingham, Alabama, United States, 35209
2
Research Site
Huntsville, Alabama, United States, 35805
3
Research Site
Beverly Hills, California, United States, 90211
4
Research Site
Chula Vista, California, United States, 91910