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Primary AldosteronismPhase 4NCT06457074

Finerenone for Patients With Primary Aldosteronism (FAIRY)

A Phase 4 study testing Finerenone Oral Tablet and Spironolactone Oral Tablet in people with Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Aldosteronism
What is being tested?
Finerenone Oral Tablet and Spironolactone Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
1 siteChina
Study dates
4 Jun 2024to 20 Apr 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • . Aged between 18-75, male or female;
  • . 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).
  • . 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;
  • . With a mean seated office SBP≥140 or DBP≥90 mmHg;
  • . Able and willing to give informed consent for participation in the clinical study;

Who cannot join

  • Has a plan to conduct PA subtype classification(eg. Adrenal vein sampling, PET-CT) in 3 months；
  • Has planned surgery within 3 months;
  • 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.
  • Night shift workers;
  • Has a body mass index(BMI) ≥30 kg/m2 at screening;
  • Has uncontrolled diabetes with fasting blood glucose(FBG)≥13.3mmol/L at screening;
Show all 25Show fewer
  • Has uncontrolled chronic diseases;
  • Has known other secondary hypertension (eg, renal artery stenosis, Cushing's syndrome, pheochromocytoma, aortic coarctation or glucocorticoid-remediable aldosteronism)
  • 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
  • Has had CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
  • Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
  • Has poor compliance that can not fully participating in the study;
  • Has hyperkalemia with serum potassium > 5.0mmol/L without potassium supplementation;
  • Has a history of uncontrolled malignant tumor;
  • Has more than 20mmHg difference of seated office SBP in both arms;
  • Is not willing or not able to stop taking sex hormones, glucocorticoids, non-steroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or antidepressants;
  • Is pregnant, breastfeeding, or planning to become pregnant during the study;
  • Complicated with severe mental illness;
  • Has had prior solid organ transplant and/or cell transplants;
  • Has a history of allergy to Finerenone or spironolactone;
  • Has typical consumption of ≥15 alcoholic drinks weekly. Note: 1 drink of alcohol is equivalent to 360ml beer, 45ml spirits, or 150ml wine;
  • Has participated in another clinical study involving any investigational drug within 30 days prior to screening；
  • Female of childbearing potential refuses to use non-hormonal contraception methods during the study period;
  • Refuse to stop eating grapefruit or grapefruit juice during treatment with Finerenone;
  • Other situations that the investigator assesses the subject as unable to complete the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the first affiliated hospital of Chongqing medical university

    Chongqing, Chongqing Municipality, 400016

Other trials in China

About this study

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

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

Read the 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.

Being tested
Finerenone Oral Tablet, Spironolactone Oral Tablet
Keywords
Primary aldosteronism, Finerenone, Spironolactone, Antihypertensive effect, Safety
Medical subject headings
Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finerenone Oral TabletDrug

    Also called Finerenone

    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).

  • Spironolactone Oral TabletDrug

    Also called Spironolactone

    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 groups in NCT06457074
Study groupRoleWhat they receive
FinerenoneExperimentalPatients divided into Finerenone group need to be treated with finerenone.
Receives: Drug: Finerenone Oral Tablet
SpironolactoneActive comparatorPatients divided into Spironolactone group need to be treated with spironolactone.
Receives: Drug: Spironolactone Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in 24-hour SBP

    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.

    Measured: 12 weeks

Secondary outcomes (12)

  1. Change from baseline in 24-hour DBP

    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.

    Measured: 12 weeks

  2. Change from baseline in daytime SBP

    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.

    Measured: 12 weeks

  3. Change from baseline in daytime DBP

    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.

    Measured: 12 weeks

  4. Change from baseline in nighttime SBP

    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.

    Measured: 12 weeks

  5. Change from baseline in nighttime DBP

    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.

    Measured: 12 weeks

  6. Blood pressure control rate at the end of the study

    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%.

    Measured: 12 weeks

  7. Serum potassium

    Change from baseline in Serum potassium, Blood was drawn to measure potassium.

    Measured: 12 weeks

  8. Hypokalemia control rate at the end of the study

    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%.

    Measured: 12 weeks

  9. Change from baseline in office SBP

    Change in office systolic blood pressure from baseline to Week 12, measured in mm Hg.

    Measured: 12 weeks

  10. Change from baseline in office DBP

    Change in office diastolic blood pressure from baseline to Week 12, measured in mm Hg.

    Measured: 12 weeks

  11. Plasma renin concentration

    Change from baseline in plasma renin concentration,Blood was drawn to measure renin.

    Measured: 12 weeks

  12. Renin normalization rate at the end of the study

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start4 Jun 2024
  3. Primary completion20 Apr 2026
  4. Study completion20 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457074
Sponsor's protocol ID
FAIRY Study
Status last verified
Apr 2026
First submitted
4 Jun 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rehan M, Raizman JE, Cavalier E, Don-Wauchope AC, Holmes DT. Laboratory challenges in primary aldosteronism screening and diagnosis. Clin Biochem. 2015 Apr;48(6):377-87. doi: 10.1016/j.clinbiochem.2015.01.003. Epub 2015 Jan 22.

    PubMed 25619896

  • Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.

    PubMed 26934393

  • Menard J. The 45-year story of the development of an anti-aldosterone more specific than spironolactone. Mol Cell Endocrinol. 2004 Mar 31;217(1-2):45-52. doi: 10.1016/j.mce.2003.10.008.

    PubMed 15134800

  • Vilela LAP, Almeida MQ. Diagnosis and management of primary aldosteronism. Arch Endocrinol Metab. 2017 May-Jun;61(3):305-312. doi: 10.1590/2359-3997000000274.

    PubMed 28699986

  • Pitt B, Kober L, Ponikowski P, Gheorghiade M, Filippatos G, Krum H, Nowack C, Kolkhof P, Kim SY, Zannad F. Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial. Eur Heart J. 2013 Aug;34(31):2453-63. doi: 10.1093/eurheartj/eht187. Epub 2013 May 27.

    PubMed 23713082

  • Agarwal R, Ruilope LM, Ruiz-Hurtado G, Haller H, Schmieder RE, Anker SD, Filippatos G, Pitt B, Rossing P, Lambelet M, Nowack C, Kolkhof P, Joseph A, Bakris GL. Effect of finerenone on ambulatory blood pressure in chronic kidney disease in type 2 diabetes. J Hypertens. 2023 Feb 1;41(2):295-302. doi: 10.1097/HJH.0000000000003330. Epub 2022 Dec 8.

    PubMed 36583355

  • Agarwal R, Pitt B, Palmer BF, Kovesdy CP, Burgess E, Filippatos G, Malyszko J, Ruilope LM, Rossignol P, Rossing P, Pecoits-Filho R, Anker SD, Joseph A, Lawatscheck R, Wilson D, Gebel M, Bakris GL. A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease. Clin Kidney J. 2022 Oct 30;16(2):293-302. doi: 10.1093/ckj/sfac234. eCollection 2023 Feb.

    PubMed 36864892

  • Filippatos G, Anker SD, Agarwal R, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Schloemer P, Tornus I, Joseph A, Bakris GL; FIDELIO-DKD Investigators. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021 Feb 9;143(6):540-552. doi: 10.1161/CIRCULATIONAHA.120.051898. Epub 2020 Nov 16.

    PubMed 33198491

  • Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.

    PubMed 26325557

  • Song Y, Yang S, He W, Hu J, Cheng Q, Wang Y, Luo T, Ma L, Zhen Q, Zhang S, Mei M, Wang Z, Qing H, Bruemmer D, Peng B, Li Q; Chongqing Primary Aldosteronism Study (CONPASS) Groupdagger. Confirmatory Tests for the Diagnosis of Primary Aldosteronism: A Prospective Diagnostic Accuracy Study. Hypertension. 2018 Jan;71(1):118-124. doi: 10.1161/HYPERTENSIONAHA.117.10197. Epub 2017 Nov 20.

    PubMed 29158354

  • Thuzar M, Young K, Ahmed AH, Ward G, Wolley M, Guo Z, Gordon RD, McWhinney BC, Ungerer JP, Stowasser M. Diagnosis of Primary Aldosteronism by Seated Saline Suppression Test-Variability Between Immunoassay and HPLC-MS/MS. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz150. doi: 10.1210/clinem/dgz150.

    PubMed 31676899

  • Mulatero P, Monticone S, Deinum J, Amar L, Prejbisz A, Zennaro MC, Beuschlein F, Rossi GP, Nishikawa T, Morganti A, Seccia TM, Lin YH, Fallo F, Widimsky J. Genetics, prevalence, screening and confirmation of primary aldosteronism: a position statement and consensus of the Working Group on Endocrine Hypertension of The European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1919-1928. doi: 10.1097/HJH.0000000000002510.

    PubMed 32890264

  • Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, Myers MG, Ogedegbe G, Schwartz JE, Townsend RR, Urbina EM, Viera AJ, White WB, Wright JT Jr. Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association. Hypertension. 2019 May;73(5):e35-e66. doi: 10.1161/HYP.0000000000000087.

    PubMed 30827125

  • Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

    PubMed 33264825

  • Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.

    PubMed 37345492

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Finerenone Oral Tablet and Spironolactone Oral Tablet in people with Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in 24-hour SBP (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457074, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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