Primary Aldosteronism Clinical Trial
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).
Status | Recruiting |
Enrollment | 306 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | the first affiliated hospital of Chongqing medical university | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Qifu Li | Changzhi Medical College, Second Affiliated Hospital, School of Medicine, Zhejiang University, The Affiliated Hospital Of Southwest Medical University, The First Affiliated Hospital of Zhengzhou University |
China,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of subjects with AEs | 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 | |
Other | Proportion of subjects with SAEs and AEs leading to discontinuation of treatment with study drug | 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 | |
Other | Change in eGFR from baseline. | Blood was drawn to measure eGFR(mL/min/1.73m2) | 12 weeks | |
Other | Change from baseline in urinary albumin-to-creatinine ratio(UACR) | Urine will be collected to measure UACR | 12 weeks | |
Other | Change from baseline in urinary Change in the UACR from baseline>30(mg/g Cr). | Urine will be collected to measure UACR | 12 weeks | |
Primary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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%. | 12 weeks | |
Secondary | Serum potassium | Change from baseline in Serum potassium, Blood was drawn to measure potassium. | 12 weeks | |
Secondary | 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%. | 12 weeks | |
Secondary | Plasma renin concentration | Change from baseline in plasma renin concentration,Blood was drawn to measure renin. | 12 weeks |
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