A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
NCT ID: NCT05432167
Last Updated: 2025-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2022-04-29
2024-05-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose CIN-107
Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
CIN-107
Patients will take CIN-107 tablets by mouth once daily.
High dose CIN-107
Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
CIN-107
Patients will take CIN-107 tablets by mouth once daily.
Placebo
Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.
Placebo
Patients will take placebo tablets by mouth once daily.
Interventions
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CIN-107
Patients will take CIN-107 tablets by mouth once daily.
Placebo
Patients will take placebo tablets by mouth once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
130 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Fountain Valley, California, United States
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Granada Hills, California, United States
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Lancaster, California, United States
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Lincoln, California, United States
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Los Angeles, California, United States
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Lynwood, California, United States
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Northridge, California, United States
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Panorama City, California, United States
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Pomona, California, United States
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Rancho Cucamonga, California, United States
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Riverside, California, United States
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San Dimas, California, United States
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South Gate, California, United States
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Tarzana, California, United States
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Vacaville, California, United States
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Victorville, California, United States
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Arvada, Colorado, United States
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Littleton, Colorado, United States
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Hollywood, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Columbus, Georgia, United States
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Decatur, Georgia, United States
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Nampa, Idaho, United States
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Chicago, Illinois, United States
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Brownsburg, Indiana, United States
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Lexington, Kentucky, United States
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Metairie, Louisiana, United States
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Monroe, Louisiana, United States
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Silver Spring, Maryland, United States
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New Bedford, Massachusetts, United States
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Flint, Michigan, United States
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Flint, Michigan, United States
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Troy, Michigan, United States
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Olive Branch, Mississippi, United States
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Kansas City, Missouri, United States
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Trenton, New Jersey, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Kinston, North Carolina, United States
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Morganton, North Carolina, United States
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Oxford, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Bethany, Oklahoma, United States
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Scottdale, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Providence, Rhode Island, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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Lampasas, Texas, United States
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Paris, Texas, United States
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Red Oak, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Alexandria, Virginia, United States
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Burke, Virginia, United States
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Charlottesville, Virginia, United States
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Manassas, Virginia, United States
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Newport News, Virginia, United States
Research Site
Salem, Virginia, United States
Research Site
Kingwood, West Virginia, United States
Countries
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References
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Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Sep 6. doi: 10.1681/ASN.0000000849. Online ahead of print. No abstract available.
Townsend RR. Blocking Aldosterone Synthesis: Whose BrigHTN Idea Was That? Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1631-1633. doi: 10.2215/CJN.0000000000000265. Epub 2023 Jul 24. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D6972C00001
Identifier Type: OTHER
Identifier Source: secondary_id
CIN-107-123
Identifier Type: -
Identifier Source: org_study_id
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