Evaluating finerenone for treating primary aldosteronism

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

This study is testing if a new medication called finerenone can help people with primary aldosteronism manage their blood pressure better than the standard treatment, spironolactone.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 306 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chongqing Medical University (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06457074 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized study aims to assess the efficacy and safety of finerenone compared to spironolactone in patients diagnosed with primary aldosteronism. Participants will be randomly assigned to receive either finerenone or spironolactone for a duration of 12 weeks. Both medications will start at a dose of 20mg per day, with adjustments made every four weeks to achieve the targeted blood pressure. The primary outcomes will be evaluated after the treatment period to determine the effectiveness of finerenone.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with a confirmed diagnosis of primary aldosteronism and elevated blood pressure.

Not a fit: Patients currently taking antihypertensive medications other than specified or those with uncontrolled conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with primary aldosteronism.

How similar studies have performed: Previous studies have shown positive outcomes with spironolactone in treating primary aldosteronism, but the efficacy of finerenone in this context is still being evaluated.

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.

Where this trial is running

Chongqing, Chongqing Municipality

• the first affiliated hospital of Chongqing medical university — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shumin Yang

Conditions: Primary Aldosteronism, Primary aldosteronism, Finerenone, Spironolactone, Antihypertensive effect, Safety