A Study of CIN-107 in Adults With Primary Aldosteronism

AstraZeneca15 enrolled

Overview

This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.

For patients in Part 1 only : The treatment duration for patients who complete all 3 dose levels, and who opt not to continue in the extension part of the study, is 12 weeks. For patients who do not complete up-titration, the treatment duration will include at least 4 weeks of dosing with the final dose level. If down-titration of CIN-107 dose is determined at Visit 6 (Week 9), the total treatment duration may be extended to 13 weeks to allow sufficient time for CIN-107 treatment effect at the final dose to be assessed. If the final dose of CIN-107 is reached before week 8 (Visit 5) and no up-titration occurs at Visit 5, the patients will be encouraged to continue CIN-107 treatment till Visit 7 for a total of 12 weeks of treatment. The patients who opt not to continue to Part 2 will not receive any study drug and will return for their safety follow up visit (Visit 8) in 2 weeks. For patients who opt to continue in the extension part (Part 2) of the study: Patients will continue to receive their dose of baxdrostat and be instructed to measure BP at least once every week prior to dosing with CIN-107 in the morning, during the extension phase. Safety surveillance will be conducted if clinically indicated. Repeat and unscheduled testing for serum potassium may be measured at the investigator's clinical site or at local laboratory for a faster turn-around time to allow clinical assessment. These patients entering part 2 will skip Visit 8 and their next visit will be Visit 9.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Aldosteronism Hyperaldosteronism

Interventions

CIN-107 2 mg dosingDRUG

One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.

CIN-107 4 mg dosingDRUG

Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.

CIN-107 8 mg dosingDRUG

Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have been diagnosed with PA. 2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment. 3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA. 4. Are willing to be compliant with the contraception and reproduction restrictions of the study. 5. Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks. Exclusion Criteria: 1. At Screening Visit, have a single occurrence of mean seated SBP \> 180 mmHg or DBP \> 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA. 2. Have a body mass index \> 45 kg/m2. 3. Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study. 4. Have a documented estimated glomerular filtration rate \< 45 mL/min/1.73 m2. 5. Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study. 6. Have known documented New York Heart Association class III or IV chronic heart failure. 7. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit. 8. Have known current severe left ventricular outflow obstruction. 9. Have had major cardiac surgery within 6 months before the Screening Visit. 10. Have a history of, or currently experiencing, clinically significant arrhythmias. 11. Have had a prior solid organ transplant or cell transplant. 12. Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen. 13. Have typical consumption of \> 14 alcoholic drinks weekly.

Locations (10)

Research Site

Greenbrae, California, United States

Research Site

San Francisco, California, United States

Research Site

West Hollywood, California, United States

Research Site

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of Treatment Emergent Adverse Events

An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.

Time frame: 74 weeks

Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism

The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.

Time frame: 12 weeks

Secondary Outcomes

Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism

The mean DBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean DBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.

Time frame: 12 weeks

The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg

The percentage of patients achieving a mean seated SBP \<140 mmHg and a mean DBP of \<90 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.

Time frame: 12 weeks

The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg

The percentage of patients achieving a mean seated SBP \<130 mmHg and a mean DBP of \<80 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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