Health TrialsbyHealthPanel

Finerenone for Patients With Primary Aldosteronism (FAIRY)

ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQifu Li

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

. 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)

. 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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Finerenone Oral Tablet

    Drug

    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 Tablet

    Drug

    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).

Treatment groups

306 Participants
are divided into 2 treatment groups
Group A: FinerenoneExperimental treatment 1 intervention
Group B: SpironolactoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
12 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
12 weeks

Other outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

Change in eGFR from baseline.

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

Time frame
12 weeks
4

Change from baseline in urinary albumin-to-creatinine ratio(UACR)

Urine will be collected to measure UACR

Time frame
12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qifu Li

Lead sponsor

Chongqing Medical University

Sponsor institution

The Affiliated Hospital Of Southwest Medical University

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

Changzhi Medical College

Collaborator

Source ClinicalTrials.gov
Apply now