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

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ClinicalTrials.gov Identifier: NCT05432167
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : September 30, 2022
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
CinCor Pharma, Inc.

Brief Summary:
This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension and Chronic Kidney Disease (CKD).

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Chronic Kidney Diseases Drug: CIN-107 Drug: Placebo Phase 2

Detailed Description:

This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uncontrolled hypertension and CKD. Approximately 300 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 4 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 27, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Low dose CIN-107
Patients will take oral tablets of CIN-107 Dose A for 26 weeks. Patients may up-titrate to take CIN-107 1 Dose B at week 3.
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 Dose C for 26 weeks. Patients may up-titrate to take CIN-107 Dose D at week 3.
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.
Drug: Placebo
Patients will take placebo tablets by mouth once daily.




Primary Outcome Measures :
  1. Change from baseline in mean seated systolic blood pressure (SBP) [ Time Frame: At Week 26 ]

Secondary Outcome Measures :
  1. Change from baseline in SBP [ Time Frame: At Week 26 ]
  2. Percentage of patients achieving SBP <130mmHg [ Time Frame: At Week 26 ]
  3. Change from baseline in urinary albumin-to-creatinine ratio (UACR) [ Time Frame: At Week 26 ]
  4. Change from baseline in diastolic blood pressure (DBP) [ Time Frame: At Week 26 ]
  5. Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: At Week 26 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) >45 kg/m2.
  • 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 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 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432167


Contacts
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Contact: Yuan-Di Halvorsen 617-675-8126 yhalvorsen@cincor.com
Contact: Nadege Briancon-Eris 617-675-8126 nbrianconeris@cincor.com

Locations
Show Show 56 study locations
Sponsors and Collaborators
CinCor Pharma, Inc.
Parexel
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Responsible Party: CinCor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05432167    
Other Study ID Numbers: CIN-107-123
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency