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

Chronic Kidney Diseases Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05432167
• Other study ID #: CIN-107-123
• Secondary ID: D6972C00001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 29, 2022
• Est. completion date: May 9, 2024

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy). The study will consist of the following 3 periods: - A Screening Period of up to 5 weeks; - A Double-Blind Treatment Period of 26 weeks; and - A Follow-Up Period of 2 weeks. Patients will complete the study in approximately 8 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 194
• Est. completion date: May 9, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic
• Uncontrolled Hypertension

Intervention

Drug:
• CIN-107
Patients will take CIN-107 tablets by mouth once daily.
• Placebo
Patients will take placebo tablets by mouth once daily.

Locations

Country	Name	City	State
United States	Research Site	Alexandria	Virginia
United States	Research Site	Arvada	Colorado
United States	Research Site	Bethany	Oklahoma
United States	Research Site	Beverly Hills	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bronx	New York
United States	Research Site	Brownsburg	Indiana
United States	Research Site	Burke	Virginia
United States	Research Site	Burlington	Vermont
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbus	Georgia
United States	Research Site	Decatur	Georgia
United States	Research Site	Durham	North Carolina
United States	Research Site	Flint	Michigan
United States	Research Site	Flint	Michigan
United States	Research Site	Fountain Valley	California
United States	Research Site	Granada Hills	California
United States	Research Site	Greenville	North Carolina
United States	Research Site	Hollywood	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kingwood	West Virginia
United States	Research Site	Kinston	North Carolina
United States	Research Site	Lampasas	Texas
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lincoln	California
United States	Research Site	Littleton	Colorado
United States	Research Site	Los Angeles	California
United States	Research Site	Lynwood	California
United States	Research Site	Manassas	Virginia
United States	Research Site	McAllen	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Metairie	Louisiana
United States	Research Site	Monroe	Louisiana
United States	Research Site	Morganton	North Carolina
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Nampa	Idaho
United States	Research Site	New Bedford	Massachusetts
United States	Research Site	Newport News	Virginia
United States	Research Site	Northridge	California
United States	Research Site	Olive Branch	Mississippi
United States	Research Site	Orlando	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Paris	Texas
United States	Research Site	Pomona	California
United States	Research Site	Providence	Rhode Island
United States	Research Site	Rancho Cucamonga	California
United States	Research Site	Red Oak	Texas
United States	Research Site	Riverside	California
United States	Research Site	S. Gate	California
United States	Research Site	Salem	Virginia
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Dimas	California
United States	Research Site	Scottdale	Pennsylvania
United States	Research Site	Smithfield	Pennsylvania
United States	Research Site	Suwanee	Georgia
United States	Research Site	Tampa	Florida
United States	Research Site	Tarzana	California
United States	Research Site	Trenton	New Jersey
United States	Research Site	Troy	Michigan
United States	Research Site	Vacaville	California
United States	Research Site	Webster	Texas
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean seated systolic blood pressure (SBP)	Change in mean seated SBP from baseline to Week 26 in patients receiving CIN-107 compared to placebo.	At Week 26
Secondary	Change from baseline in SBP in CIN-107 compared to placebo in patients assigned to the high-dose strategy group	Change in mean seated SBP from baseline to Week 26 in patients receiving high-dose CIN-107 compared to placebo	At Week 26
Secondary	Change from baseline of SBP in CIN-107 compared to placebo in patients assigned to the low-dose strategy group	Change in mean seated SBP from baseline to Week 26 in patients receiving low-dose CIN-107 compared to placebo	At Week 26