A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
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
2 other identifiers
interventional
195
1 country
71
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2022
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2024
CompletedResults Posted
Study results publicly available
May 20, 2025
CompletedMay 20, 2025
April 1, 2025
2 years
June 20, 2022
March 25, 2025
May 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo
Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.
At Week 26
Secondary Outcomes (2)
Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group
At Week 26
Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group
At Week 26
Other Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Study Arms (3)
Low dose CIN-107
EXPERIMENTALPatients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
High dose CIN-107
EXPERIMENTALPatients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.
Placebo
PLACEBO COMPARATORPatients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (71)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Huntsville, Alabama, 35805, United States
Research Site
Beverly Hills, California, 90211, United States
Research Site
Chula Vista, California, 91910, United States
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Fountain Valley, California, 92708, United States
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Granada Hills, California, 91344, United States
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Lancaster, California, 93534, United States
Research Site
Lincoln, California, 95648, United States
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Los Angeles, California, 90010, United States
Research Site
Lynwood, California, 90262, United States
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Northridge, California, 91324, United States
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Panorama City, California, 91402, United States
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Pomona, California, 91767, United States
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Rancho Cucamonga, California, 91730, United States
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Riverside, California, 92503, United States
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San Dimas, California, 91773, United States
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South Gate, California, 90280, United States
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Tarzana, California, 91356, United States
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Vacaville, California, 95687, United States
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Victorville, California, 92392, United States
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Arvada, Colorado, 80002, United States
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Littleton, Colorado, 80120, United States
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Hollywood, Florida, 33021, United States
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Orlando, Florida, 32807, United States
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Orlando, Florida, 32808, United States
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Tampa, Florida, 33612, United States
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West Palm Beach, Florida, 33401, United States
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Columbus, Georgia, 31904, United States
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Decatur, Georgia, 30030, United States
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Nampa, Idaho, 83687, United States
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Chicago, Illinois, 60643, United States
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Brownsburg, Indiana, 46112, United States
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Lexington, Kentucky, 40503, United States
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Metairie, Louisiana, 70006, United States
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Monroe, Louisiana, 71201, United States
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Silver Spring, Maryland, 20904, United States
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New Bedford, Massachusetts, 02740, United States
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Flint, Michigan, 48504, United States
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Flint, Michigan, 48532, United States
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Troy, Michigan, 48085, United States
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Olive Branch, Mississippi, 38654, United States
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Kansas City, Missouri, 64111, United States
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Trenton, New Jersey, 08611, United States
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The Bronx, New York, 10455, United States
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Durham, North Carolina, 27704, United States
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Greenville, North Carolina, 27834, United States
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Kinston, North Carolina, 28504, United States
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Morganton, North Carolina, 28655, United States
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Oxford, North Carolina, 27565, United States
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Wilmington, North Carolina, 28401, United States
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Cincinnati, Ohio, 45246, United States
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Bethany, Oklahoma, 73008, United States
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Scottdale, Pennsylvania, 15683, United States
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Smithfield, Pennsylvania, 15478, United States
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Providence, Rhode Island, 02903, United States
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Memphis, Tennessee, 38119, United States
Research Site
Houston, Texas, 77099, United States
Research Site
Lampasas, Texas, 76550, United States
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Paris, Texas, 75462, United States
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Red Oak, Texas, 75154, United States
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San Antonio, Texas, 78212, United States
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San Antonio, Texas, 78249, United States
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Salt Lake City, Utah, 84132, United States
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Burlington, Vermont, 05401, United States
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Alexandria, Virginia, 22304, United States
Research Site
Burke, Virginia, 22015, United States
Research Site
Charlottesville, Virginia, 22908, United States
Research Site
Manassas, Virginia, 20110, United States
Research Site
Newport News, Virginia, 23606, United States
Research Site
Salem, Virginia, 24153, United States
Research Site
Kingwood, West Virginia, 26537, United States
Related Publications (2)
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.
PMID: 40913594DERIVEDTownsend 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.
PMID: 37490693DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 27, 2022
Study Start
April 29, 2022
Primary Completion
May 2, 2024
Study Completion
May 2, 2024
Last Updated
May 20, 2025
Results First Posted
May 20, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.