Finerenone for Patients With Primary Aldosteronism (FAIRY)

Phase 4

Recruiting

• Conditions: Primary Aldosteronism
• Interventions: Drug: Spironolactone Oral Tablet; Drug: Finerenone Oral Tablet

• Registration Number: NCT06457074
• Lead Sponsor: Qifu Li

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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-06-04
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-08
• Study First Posted: 2024-06-13
• Last Update Submitted: 2024-08-04
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spironolactone	Spironolactone Oral Tablet	Patients divided into Spironolactone group need to be treated with spironolactone.
Finerenone	Finerenone Oral Tablet	Patients divided into Finerenone group need to be treated with finerenone.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Serum potassium	12 weeks	Change from baseline in Serum potassium, Blood was drawn to measure potassium.
Plasma renin concentration	12 weeks	Change from baseline in plasma renin concentration,Blood was drawn to measure renin.
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 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.
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%.
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%.

Trial Locations

Locations (1)

the first affiliated hospital of Chongqing medical university; 🇨🇳 Chongqing, Chongqing, China