Clinical trial NCT06457074: Finerenone for Patients With Primary Aldosteronism (FAIRY)
Official title: Finerenone for Patients With Primary Aldosteronism (FAIRY): A Multicenter, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Primary Aldosteronism
Keywords: Primary aldosteronism
Finerenone
Spironolactone
Antihypertensive effect
Safety
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Southwest Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Changzhi Medical College
First posted: 2024-06-13
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).

Detailed description: This is a multicenter, randomized study designed to evaluate efficacy and safety of finerenone in patients with PA. PA patients are randomly divided into two groups and treated with finerenone or spironolactone for 12 weeks. Spironolactone will be used as the control, while outcome will be assessed after 12-week treatment. Both drugs will be started at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure.

Eligibility criteria: Inclusion Criteria:

1. . Aged between 18-75, male or female;
2. . With confirmed PA diagnosis (screening positive and at least one confirmatory test is positive); NOTE: Screening positive was defined as plasma aldosterone-to-renin ratio (ARR)

   ≥ 20(pg/ml)/(μIU/ml) or ARR≥30(ng/dL)/(ng/ml/hr). Plasma aldosterone concentration (PAC) post captopril challenge test (CCT) ≥ 110 pg/ml or PAC post seated saline infusion test (SSIT) ≥ 80 pg/ml was considered positive. Note: ARR≥10(pg/ml)/(μIU/ml) or ARR≥15(ng/dL)/(ng/ml/hr) can be considered positive if the patients with hypokalemia (serum potassium \< 3.5mmol/L) or adrenal nodules (diameter \> 1cm).
3. . Not taking any antihypertensive drugs or on a stable regimen of antihypertensive agents(Limited to alpha-adrenergic receptor blockers and calcium channel blockers.) for more than four weeks before screening;
4. . With a mean seated office SBP≥140 or DBP≥90 mmHg;
5. . Able and willing to give informed consent for participation in the clinical study;

Exclusion Criteria:

1. Has a plan to conduct PA subtype classification(eg. Adrenal vein sampling, PET-CT) in 3 months；
2. Has planned surgery within 3 months;
3. With a mean seated office SBP ≥ 180mmHg or DBP ≥ 110mmHg before randomization; Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit. If the patient did not take their regularly scheduled antihypertensive medications prior to the visit, 1 BP re-test is allowed within 2 days after taking the medications.
4. Night shift workers;
5. Has a body mass index(BMI) ≥30 kg/m2 at screening;
6. Has uncontrolled diabetes with fasting blood glucose(FBG)≥13.3mmol/L at screening;
7. Has uncontrolled chronic diseases;
8. Has known other secondary hypertension (eg, renal artery stenosis, Cushing's syndrome, pheochromocytoma, or aortic coarctation) except subclinical Cushing's syndrome;
9. Has known and documented heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal;
10. Has had CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
11. Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
12. Has poor compliance that can not fully participating in the study;
13. Has hyperkalemia with serum potassium \> 5.0mmol/L without potassium supplementation;
14. Has a history of uncontrolled malignant tumor;
15. Has more than 20mmHg difference of seated office SBP in both arms;
16. Is not willing or not able to stop taking sex hormones, glucocorticoids, non-steroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or antidepressants;
17. Is pregnant, breastfeeding, or planning to become pregnant during the study;
18. Complicated with severe mental illness;
19. Has had prior solid organ transplant and/or cell transplants;
20. Has a history of allergy to Finerenone or spironolactone;
21. Has typical consumption of ≥15 alcoholic drinks weekly. Note: 1 drink of alcohol is equivalent to 360ml beer, 45ml spirits, or 150ml wine;
22. Has participated in another clinical study involving any investigational drug within 30 days prior to screening；
23. Female of childbearing potential refuses to use non-hormonal contraception methods during the study period;
24. Refuse to stop eating grapefruit or grapefruit juice during treatment with Finerenone;
25. Other situations that the investigator assesses the subject as unable to complete the trial.

Primary outcomes:
measure: Change from baseline in 24-hour SBP
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in 24-hour DBP
timeFrame: 12 weeks
measure: Change from baseline in daytime SBP
timeFrame: 12 weeks
measure: Change from baseline in daytime DBP
timeFrame: 12 weeks
measure: Change from baseline in nighttime SBP
timeFrame: 12 weeks
measure: Change from baseline in nighttime DBP
timeFrame: 12 weeks
measure: Blood pressure control rate at the end of the study
timeFrame: 12 weeks
measure: Serum potassium
timeFrame: 12 weeks
measure: Hypokalemia control rate at the end of the study
timeFrame: 12 weeks
measure: Plasma renin concentration
timeFrame: 12 weeks
Other outcomes:
measure: Proportion of subjects with AEs
timeFrame: 12 weeks
measure: Proportion of subjects with SAEs and AEs leading to discontinuation of treatment with study drug
timeFrame: 12 weeks
measure: Change in eGFR from baseline.
timeFrame: 12 weeks
measure: Change from baseline in urinary albumin-to-creatinine ratio(UACR)
timeFrame: 12 weeks
measure: Change from baseline in urinary Change in the UACR from baseline>30(mg/g Cr).
timeFrame: 12 weeks
Locations:
city: Chongqing
country: China
facility: the first affiliated hospital of Chongqing medical university
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Shumin Yang
role: STUDY_CHAIR
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