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

FAIRY Study

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

2024-05-30

2025-06-01

2026-06-01

Recruiting

Early phase I

306

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 306, 'type': 'ESTIMATED'}}

2024-06-13