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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases; Uncontrolled Hypertension
• Intervention / Treatment: Drug: CIN-107; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Research Site
    • Huntsville, Alabama, United States, 35805
      • Research Site
  • California
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Chula Vista, California, United States, 91910
      • Research Site
    • Fountain Valley, California, United States, 92708
      • Research Site
    • Granada Hills, California, United States, 91344
      • Research Site
    • Lincoln, California, United States, 95648
      • Research Site
    • Los Angeles, California, United States, 90010
      • Research Site
    • Lynwood, California, United States, 90262
      • Research Site
    • Northridge, California, United States, 91324
      • Research Site
    • Pomona, California, United States, 91767
      • Research Site
    • Rancho Cucamonga, California, United States, 91730
      • Research Site
    • Riverside, California, United States, 92503
      • Research Site
    • S. Gate, California, United States, 90280
      • Research Site
    • San Dimas, California, United States, 91773
      • Research Site
    • Tarzana, California, United States, 91356
      • Research Site
    • Vacaville, California, United States, 95687
      • Research Site
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Research Site
    • Littleton, Colorado, United States, 80120
      • Research Site
  • Florida
    • Hollywood, Florida, United States, 33021
      • Research Site
    • Orlando, Florida, United States, 32808
      • Research Site
    • Orlando, Florida, United States, 32807
      • Research Site
    • Tampa, Florida, United States, 33612
      • Research Site
    • West Palm Beach, Florida, United States, 33401
      • Research Site
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Research Site
    • Decatur, Georgia, United States, 30030
      • Research Site
    • Suwanee, Georgia, United States, 30024
      • Research Site
  • Idaho
    • Nampa, Idaho, United States, 83687
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research Site
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Research Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Research Site
    • Monroe, Louisiana, United States, 71201
      • Research Site
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • Research Site
  • Michigan
    • Flint, Michigan, United States, 48504
      • Research Site
    • Flint, Michigan, United States, 48532
      • Research Site
    • Troy, Michigan, United States, 48085
      • Research Site
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Research Site
  • New York
    • Bronx, New York, United States, 10455
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Research Site
    • Durham, North Carolina, United States, 27704
      • Research Site
    • Greenville, North Carolina, United States, 27834
      • Research Site
    • Kinston, North Carolina, United States, 28504
      • Research Site
    • Morganton, North Carolina, United States, 28655
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Research Site
  • Oklahoma
    • Bethany, Oklahoma, United States, 73008
      • Research Site
  • Pennsylvania
    • Scottdale, Pennsylvania, United States, 15683
      • Research Site
    • Smithfield, Pennsylvania, United States, 15478
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Site
  • Texas
    • Houston, Texas, United States, 77099
      • Research Site
    • Lampasas, Texas, United States, 76550
      • Research Site
    • McAllen, Texas, United States, 78503
      • Research Site
    • Paris, Texas, United States, 75462
      • Research Site
    • Red Oak, Texas, United States, 75154
      • Research Site
    • San Antonio, Texas, United States, 78249
      • Research Site
    • San Antonio, Texas, United States, 78212
      • Research Site
    • Webster, Texas, United States, 77598
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Research Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Research Site
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Research Site
    • Burke, Virginia, United States, 22015
      • Research Site
    • Charlottesville, Virginia, United States, 22908
      • Research Site
    • Manassas, Virginia, United States, 20110
      • Research Site
    • Newport News, Virginia, United States, 23606
      • Research Site
    • Salem, Virginia, United States, 24153
      • Research Site
  • West Virginia
    • Kingwood, West Virginia, United States, 26537
      • Research Site
    • Morgantown, West Virginia, United States, 26505
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose CIN-107; Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.	Drug: CIN-107; Patients will take CIN-107 tablets by mouth once daily.
Experimental: High dose CIN-107; Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.	Drug: CIN-107; Patients will take CIN-107 tablets by mouth once daily.
Placebo Comparator: Placebo; Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.	Drug: Placebo; Patients will take placebo tablets by mouth once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Estimated): March 5, 2024
• Study Completion (Estimated): May 9, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: CIN-107-123; D6972C00001 (Other Identifier: AstraZeneca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No