Clinical trial NCT05432167: A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncontrolled Hypertension
Chronic Kidney Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2022-06-27
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo
timeFrame: At Week 26
Secondary outcomes:
measure: Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group
timeFrame: At Week 26
measure: Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group
timeFrame: At Week 26
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Granada Hills
country: United States
facility: Research Site
state: California
city: Lancaster
country: United States
facility: Research Site
state: California
city: Lincoln
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Lynwood
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: Panorama City
country: United States
facility: Research Site
state: California
city: Pomona
country: United States
facility: Research Site
state: California
city: Rancho Cucamonga
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
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state: California
city: S. Gate
country: United States
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state: California
city: San Dimas
country: United States
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state: California
city: Tarzana
country: United States
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state: California
city: Vacaville
country: United States
facility: Research Site
state: California
city: Victorville
country: United States
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state: California
city: Arvada
country: United States
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state: Colorado
city: Littleton
country: United States
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state: Colorado
city: Hollywood
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: West Palm Beach
country: United States
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state: Florida
city: Columbus
country: United States
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state: Georgia
city: Decatur
country: United States
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state: Georgia
city: Nampa
country: United States
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state: Idaho
city: Chicago
country: United States
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state: Illinois
city: Brownsburg
country: United States
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state: Indiana
city: Lexington
country: United States
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state: Kentucky
city: Metairie
country: United States
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state: Louisiana
city: Monroe
country: United States
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state: Louisiana
city: Silver Spring
country: United States
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state: Maryland
city: New Bedford
country: United States
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state: Massachusetts
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Troy
country: United States
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state: Michigan
city: Olive Branch
country: United States
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state: Mississippi
city: Kansas City
country: United States
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state: Missouri
city: Trenton
country: United States
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state: New Jersey
city: Bronx
country: United States
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state: New York
city: Durham
country: United States
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state: North Carolina
city: Greenville
country: United States
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state: North Carolina
city: Kinston
country: United States
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state: North Carolina
city: Morganton
country: United States
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state: North Carolina
city: Oxford
country: United States
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state: North Carolina
city: Wilmington
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Bethany
country: United States
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state: Oklahoma
city: Scottdale
country: United States
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state: Pennsylvania
city: Smithfield
country: United States
facility: Research Site
state: Pennsylvania
city: Providence
country: United States
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state: Rhode Island
city: Memphis
country: United States
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state: Tennessee
city: Houston
country: United States
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state: Texas
city: Lampasas
country: United States
facility: Research Site
state: Texas
city: Paris
country: United States
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state: Texas
city: Red Oak
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Salt Lake City
country: United States
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state: Utah
city: Burlington
country: United States
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state: Vermont
city: Alexandria
country: United States
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state: Virginia
city: Burke
country: United States
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state: Virginia
city: Charlottesville
country: United States
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state: Virginia
city: Manassas
country: United States
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state: Virginia
city: Newport News
country: United States
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state: Virginia
city: Salem
country: United States
facility: Research Site
state: Virginia
city: Kingwood
country: United States
facility: Research Site
state: West Virginia
Study officials:
References: