Finerenone for Patients With Primary Aldosteronism (FAIRY)

Finerenone for Patients With Primary Aldosteronism (FAIRY): A Multicenter, Randomized Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06457074

Enrollment

306

Registered

2024-06-13

Start date

2024-06-04

Completion date

2026-04-20

Last updated

2026-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

Primary aldosteronism, Finerenone, Spironolactone, Antihypertensive effect, Safety

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.

Interventions

DRUGFinerenone Oral Tablet

Eligible patients will be started finerenone at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure (the mean office blood pressure \<140/90 mmHg).

DRUGSpironolactone Oral Tablet

Eligible patients will be started spironolactone at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure (the mean office blood pressure \<140/90 mmHg).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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, aortic coarctation or glucocorticoid-remediable aldosteronism) 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; or has an estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m2 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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in 24-hour SBP	12 weeks	Change from baseline in 24-hour systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.

Secondary

Measure	Time frame	Description
Change from baseline in 24-hour DBP	12 weeks	Change from baseline in 24-hour diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Change from baseline in daytime SBP	12 weeks	Change from baseline in daytime systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Change from baseline in daytime DBP	12 weeks	Change from baseline in daytime diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Change from baseline in nighttime SBP	12 weeks	Change from baseline in nighttime systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Change from baseline in nighttime DBP	12 weeks	Change from baseline in nighttime diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Blood pressure control rate at the end of the study	12 weeks	Blood pressure control rate was defined as the number of patients with blood pressure controlled (with mean seated office BP\<140/90mmHg at the end of the study)/ total number of patients in each group × 100%.
Serum potassium	12 weeks	Change from baseline in Serum potassium, Blood was drawn to measure potassium.
Hypokalemia control rate at the end of the study	12 weeks	Hypokalemia control rate was defined as the number of hypokalemic patients with serum potassium\>3.5mmol/l at the end of the study/number of hypokalemic patients at baseline× 100%.
Change from baseline in office SBP	12 weeks	Change in office systolic blood pressure from baseline to Week 12, measured in mm Hg.
Change from baseline in office DBP	12 weeks	Change in office diastolic blood pressure from baseline to Week 12, measured in mm Hg.
Plasma renin concentration	12 weeks	Change from baseline in plasma renin concentration,Blood was drawn to measure renin.
Renin normalization rate at the end of the study	12 weeks	The renin normalization rate was defined as the proportion of patients with suppressed renin at baseline who achieved a renin level \>10 μIU/ml at the end of the study.

Countries

China

Contacts

STUDY_CHAIRShumin Yang

First Affiliated Hospital of Chongqing Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 26, 2026