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A Study of CIN-107 in Adults With Primary Aldosteronism (spark-PA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605549
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
CinCor Pharma, Inc.

Brief Summary:
This is a Phase 2, randomized, placebo-controlled, multicenter, parallel-group, dose-ranging study in patients with PA to evaluate the efficacy and safety of up to 3 doses of CIN-107 as compared to placebo after 4 weeks of treatment.

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Hyperaldosteronism Drug: CIN-107 Dose 1 Drug: CIN-107 Dose 2 Drug: CIN-107 Dose 3 Drug: Placebo for CIN-107 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of CIN-107 for the Treatment of Patients With Primary Aldosteronism (PA)
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CIN-107 Dose 1 Drug: CIN-107 Dose 1
CIN-107 tablets by mouth once daily

Experimental: CIN-107 Dose 2 Drug: CIN-107 Dose 2
CIN-107 tablets by mouth once daily

Experimental: CIN-107 Dose 3 Drug: CIN-107 Dose 3
CIN-107 tablets by mouth once daily

Placebo Comparator: Placebo for CIN-107 Drug: Placebo for CIN-107
Placebo for CIN-107 tablets by mouth once daily




Primary Outcome Measures :
  1. Change from baseline in mean seated systolic blood pressure (SBP) [ Time Frame: 4 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline in mean diastolic blood pressure (DBP) [ Time Frame: 4 Weeks ]
  2. The percentage of patients achieving a seated BP response <140/90 mmHg [ Time Frame: 4 Weeks ]
  3. The percentage of patients achieving a seated BP response <130/80 mmHg [ Time Frame: 4 Weeks ]
  4. The percentage of patients achieving either a plasma aldosterone concentration (PAC <15 ng/dL and a plasma renin activity (PRA) >=0.5 ng/mL/hr; or an aldosterone-to-renin ratio (ARR) <30. [ Time Frame: 4 Weeks ]


Information from the National Library of Medicine

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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:

  • Adults (18 years of age or older) with a diagnosis or suspected diagnosis of PA;
  • Is able to wash out of protocol-specified antihypertensive medication(s) for up to 4 weeks and remain washed out for the duration of the study treatment period; and
  • Is willing to take allowed, protocol-specified medication(s), if needed, to maintain BP within protocol parameters.

Exclusion Criteria:

  • Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
  • Has a BMI >40 kg/m2 and an arm circumference <7 and >17 inches;
  • Has had a previous surgical intervention or has a planned surgical intervention for an adrenal adenoma or adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study;
  • Has a documented estimated glomerular filtration rate <45 mL/min/1.73m2;
  • Has a planned dialysis or kidney transplantation during the course of the study;
  • Has known documented chronic heart failure;
  • Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit;
  • Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease, diagnosed from a prior echocardiogram;
  • Has a planned or has had within 6 months of the Screening Visit a coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) or any major surgical procedure during the study;
  • Has chronic permanent atrial fibrillation;
  • Plans to be on night shifts during the course of the study;
  • Has typical consumption of >14 alcoholic drinks weekly;
  • Potassium <2.5 mEq/L; and,
  • Potassium >5.0 mEq/L.

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): NCT04605549


Contacts
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Contact: Brendan Doran, PharmD 513-579-9911 ext 11242 bdoran@cincor.com

Locations
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United States, Alabama
CinCor Site 07 Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
CinCor Site 08 Not yet recruiting
Phoenix, Arizona, United States, 85012
United States, California
CinCor Site 05 Recruiting
Greenbrae, California, United States, 94904
CinCor Site 16 Not yet recruiting
Los Angeles, California, United States, 90048
CinCor Site 03 Not yet recruiting
San Francisco, California, United States, 94110
CinCor Site 10 Not yet recruiting
Stanford, California, United States, 94305
United States, Georgia
CinCor Site 14 Recruiting
Atlanta, Georgia, United States, 30328
United States, Illinois
CinCor Site 12 Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Maryland
CinCor Site 04 Not yet recruiting
Baltimore, Maryland, United States, 21287
United States, Michigan
CinCor Site 02 Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
CinCor Site 01 Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
CinCor Site 11 Not yet recruiting
Cincinnati, Ohio, United States, 45229
CinCor Site 15 Not yet recruiting
Cincinnati, Ohio, United States, 45245
CinCor Site 09 Not yet recruiting
Columbus, Ohio, United States, 43210
United States, Texas
CinCor Site 06 Recruiting
Houston, Texas, United States, 77002
Sponsors and Collaborators
CinCor Pharma, Inc.
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Responsible Party: CinCor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04605549    
Other Study ID Numbers: CIN-107-122
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CinCor Pharma, Inc.:
Primary Aldosteronism
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases