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Finerenon dla pacjentów z pierwotnym aldosteronizmem (FAIRY)

22 września 2026 zaktualizowane przez: Qifu Li, Chongqing Medical University

Finerenon dla pacjentów z pierwotnym aldosteronizmem (FAIRY): wieloośrodkowe, randomizowane badanie kliniczne

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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

306

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Chiny, 400016
        • the first affiliated hospital of Chongqing medical university

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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, aortic coarctation or glucocorticoid-remediable aldosteronism)
  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; or has an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m2
  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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Finerenone

Patients divided into Finerenone group need to be treated with 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).

Inne nazwy:
  • Finerenon
Aktywny komparator: Spironolactone

Patients divided into Spironolactone group need to be treated with 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).

Inne nazwy:
  • Spironolakton

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in 24-hour SBP
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in 24-hour DBP
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Change from baseline in office SBP
Ramy czasowe: 12 weeks

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

12 weeks
Change from baseline in office DBP
Ramy czasowe: 12 weeks

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

12 weeks
Plasma renin concentration
Ramy czasowe: 12 weeks

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

12 weeks
Renin normalization rate at the end of the study
Ramy czasowe: 12 weeks

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.

12 weeks

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in eGFR from baseline.
Ramy czasowe: 12 weeks

Blood was drawn to measure eGFR(mL/min/1.73m2)

12 weeks
Change from baseline in urinary albumin-to-creatinine ratio(UACR)
Ramy czasowe: 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).
Ramy czasowe: 12 weeks

Urine will be collected to measure UACR

12 weeks
Change from baseline in NT-proBNP
Ramy czasowe: 12 weeks

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration from baseline to Week 12, measured in pg/mL.

12 weeks
Changes from baseline in high-sensitivity C-reactive protein (hs-CRP)
Ramy czasowe: 12 weeks

Change in high-sensitivity C-reactive protein (hs-CRP) from baseline to Week 12, measured in mg/L.

12 weeks
Occurrence of adverse events
Ramy czasowe: 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
Occurrence of serious adverse events
Ramy czasowe: 12 weeks

Number and proportion of participants who experienced one or more serious adverse events during the 12-week treatment period.

12 weeks
Adverse events considered related to the study drug that led to discontinuation of the study drug;
Ramy czasowe: 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
Adverse events of special interest in this study
Ramy czasowe: 12 weeks

Number and proportion of participants who experienced one or more adverse events of special interest during the 12-week treatment period. Adverse events of special interest included hyperkalemia, hypotension, >30% decline in eGFR, acute kidney injury, and sex hormone-related adverse events.

12 weeks
Adverse events other than those prespecified as adverse events of special interest that occurred in at least 5% of participants in either treatment group
Ramy czasowe: 12 weeks

Number and proportion of participants who experienced adverse events other than prespecified adverse events of special interest that occurred in at least 5% of participants in either treatment group during the 12-week treatment period.

12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Krzesło do nauki: Shumin Yang, First Affiliated Hospital of Chongqing Medical University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 czerwca 2024

Zakończenie podstawowe (Rzeczywisty)

20 kwietnia 2026

Ukończenie studiów (Rzeczywisty)

20 kwietnia 2026

Daty rejestracji na studia

Pierwszy przesłany

4 czerwca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 czerwca 2024

Pierwszy wysłany (Rzeczywisty)

13 czerwca 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 września 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • FAIRY Study

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .