Finerenone for Patients With Primary Aldosteronism (FAIRY)

August 28, 2024 updated by: Qifu Li

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

306

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Finerenone
Patients divided into Finerenone group need to be treated with finerenone.
Drug: Finerenone 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).
Other Names:
  • Finerenone
Active Comparator: Spironolactone
Patients divided into Spironolactone group need to be treated with spironolactone.
Drug: Spironolactone 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).
Other Names:
  • Spironolactone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in 24-hour SBP
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in 24-hour DBP
Time Frame: 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.
12 weeks
Change from baseline in daytime SBP
Time Frame: 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.
12 weeks
Change from baseline in daytime DBP
Time Frame: 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.
12 weeks
Change from baseline in nighttime SBP
Time Frame: 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.
12 weeks
Change from baseline in nighttime DBP
Time Frame: 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.
12 weeks
Blood pressure control rate at the end of the study
Time Frame: 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%.
12 weeks
Serum potassium
Time Frame: 12 weeks
Change from baseline in Serum potassium, Blood was drawn to measure potassium.
12 weeks
Hypokalemia control rate at the end of the study
Time Frame: 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%.
12 weeks
Plasma renin concentration
Time Frame: 12 weeks
Change from baseline in plasma renin concentration,Blood was drawn to measure renin.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with AEs
Time Frame: 12 weeks
Adverse events(AEs) defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
12 weeks
Proportion of subjects with SAEs and AEs leading to discontinuation of treatment with study drug
Time Frame: 12 weeks
Serious adverse events(SAEs) results in any of the following outcomes:Death;A life-threatening AE;Requires hospitalization or prolongation of existing hospitalizations;A persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions.
12 weeks
Change in eGFR from baseline.
Time Frame: 12 weeks
Blood was drawn to measure eGFR（mL/min/1.73m2）
12 weeks
Change from baseline in urinary albumin-to-creatinine ratio(UACR)
Time Frame: 12 weeks
Urine will be collected to measure UACR
12 weeks
Change from baseline in urinary Change in the UACR from baseline>30(mg/g Cr).
Time Frame: 12 weeks
Urine will be collected to measure UACR
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qifu Li

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
The First Affiliated Hospital of Zhengzhou University
Changzhi Medical College
The Affiliated Hospital Of Southwest Medical University

Investigators

  • Study Chair: Shumin Yang, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 8, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAIRY Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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