Primary AldosteronismPhase 4NCT06381323
The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism
A Phase 4 study testing Finerenone in people with Primary Aldosteronism and Finerenone, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism, Finerenone, Mineralocorticoid Receptor Antagonist
- What is being tested?
- Finerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Jun 2025
- 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
- Age:18-75 years old.
- History of hypertension, with a sitting SBP ≥140 and <180 mmHg, and a sitting DBP ≥90 and <120 mmHg during the last two evaluations within the observation period.
- Patients with PA who are eligible for drug treatment.
- Diagnostic criteria for primary aldosteronism: (1) Hypertension or use of antihypertensive medications, with or without hypokalemia; (2) Screening test: Baseline plasma aldosterone to renin ratio (ARR) >30 (ng/dl)/(ng/ml/h) or ARR >2.4 (ng/dl)/(mU/L), with plasma aldosterone >15 ng/dl and plasma renin activity <1.0 ng/ml/h; (3) At least one confirmed test is positive: ① After a captopril test, plasma aldosterone decreases by <30% or plasma aldosterone is ≥11 ng/dl, with suppressed renin activity; ② Sitting saline infusion test results in a plasma aldosterone ≥10 ng/dl.
- eGFR ≥60 ml/ (min*1.73m2).
- Signed informed consent form.
Who cannot join
- Other secondary hypertension (such as renal vascular hypertension, Cushing's syndrome, subclinical Cushing's syndrome, and pheochromocytoma) or hypertensive crisis.
- Orthostatic hypotension.
- Heart failure, acute myocardial infarction, stroke, transient ischemic attack, or other acute cardiovascular events within the past 6 months.
- History of adrenal surgery within the past 6 months.
- History of carotid artery surgery within the past 6 months.
- History of arterial vascular reconstruction surgery within the past 6 months.
Show all 15Show fewer
- Hospitalization within the past year due to severe hyperkalemia, with serum potassium levels <2.5 or ≥5.0 mmol/L.
- Abnormal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5× upper limit of normal (ULN), total bilirubin (TBIL) > 1.5× ULN.
- Use of spironolactone, hydralazine, or minoxidil within 30 days prior to enrollment.
- Concurrent use of potent CYP3A4 inhibitors or inducers for treatment.
- Known or suspected tumors; other autoimmune diseases, uncontrolled infectious diseases, severe respiratory, blood, and neurological diseases.
- Pregnancy or planning pregnancy within 3 months before or after treatment, and breastfeeding women.
- Mental illness, alcohol or drug abuse, inability to cooperate with treatment.
- Patients with pacemakers.
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: Study on the Clinical Efficacy and Safety of the New Mineralocorticoid Receptor Antagonist Finerenone in the Treatment of Primary Aldosteronism: a Multicenter, Prospective, Open-label Clinical Study
The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism.
Read the detailed description
Primary aldosteronism(PA) is a clinical syndrome characterized by autonomous aldosterone secretion in the body caused by adrenal cortical adenoma or hyperplasia not regulated by renin, angiotensin II, and sodium status regulation. It is the most common cause of secondary hypertension, accounting for about 10% of all hypertensive patients. The latest prospective study in China showed that the prevalence of primary aldosteronism in newly diagnosed hypertensive patients was 4%, with an additional 3% of suspicious primary aldosteronism patients. Excessive activation of the mineralocorticoid receptor (MR) in the body leads to well-known increased circulating volume overload, hypertension, and hypokalemia, as well as significantly increased cardiovascular, renal, and mortality risks. Therefore, primary aldosteronism is currently considered a new public health problem and has important implications for early diagnosis and precise treatment of primary aldosteronism.
Only about 30% of patients with PA (aldosterone-producing adenoma or unilateral adrenal hyperplasia) can be cured or relieved through surgical resection, while about 65% of patients with primary aldosteronism caused by bilateral adrenal cortical hyperplasia require drug treatment. Currently, the only available drug in China is the first-generation mineralocorticoid receptor antagonist, spironolactone, which is greatly limited in its use due to its significant side effects on the gonads caused by the blockade of androgens and progesterones. Another MRA, eplerenone, which has not yet been marketed in China, is expensive and clinically inferior to spironolactone. Therefore, a large number of patients with primary aldosteronism are currently not using or using low doses of spironolactone, unable to fully counteract the high aldosterone effect, and unable to effectively control the risk of cardiovascular and renal damage. Therefore, it is necessary to explore new drugs for the treatment of primary aldosteronism.
Finerenone is a newly developed novel non-steroidal MRA, which has higher affinity and selectivity for MR binding compared to steroidal MRA (spironolactone or eplerenone). Existing clinical research results suggest that Finerenone can effectively reduce the risk of cardiovascular and renal damage in patients with chronic kidney disease and diabetes, and has good safety.
This study aims to be the first internationally to conduct clinical research on the use of the novel mineralocorticoid receptor antagonist finerenone for the treatment of primary aldosteronism. Through a multicenter, prospective, open-label study, the clinical efficacy and safety of this medication will be clearly established, providing high-level evidence of the use of finerenone in patients with primary aldosteronism. The project's results will offer a new option for the pharmacological treatment of primary aldosteronism, with the goal of better controlling patients' biochemical abnormalities, effectively reducing the risk of cardiovascular and renal damage, and improving disease prognosis.
- Being tested
- Finerenone
- Keywords
- Primary Aldosteronism, Finerenone, Mineralocorticoid Receptor Antagonist, Hypertension, 24-hour ambulatory blood pressure monitoring, Daytime SBP
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Also called Nifedipine
All eligible subjects enter a 2-week enrollment phase and only take stable doses of controlled-release nifedipine. After completing baseline examinations, subjects with SBP <180 and ≥140 mmHg and DBP <120 and ≥90 mmHg enter the follow-up phase of the treatment period. Eligible subjects receive a starting dose of 20 mg qd of Finerenone. If the blood pressure is still ≥140/90 mmHg at week 4, serum potassium is <5.0 mmol/L, and eGFR has decreased <30% compared to baseline, the Finerenone dose is adjusted to 40 mg qd.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Recruitment of diagnosed patients with PA from multiple centers, confirmation of subject eligibility according to inclusion criteria and exclusion criteria, and signing of informed consent forms. All eligible subjects enter a 2-week enrollment phase and only take stable doses of controlled-release nifedipine. After completing baseline examinations, subjects with SBP <180 and ≥140 mmHg and DBP <120 and ≥90 mmHg enter the follow-up phase of the treatment period. Eligible subjects receive a starting dose of 20 mg qd of Finerenone. If the blood pressure is still ≥140/90 mmHg at week 4, serum potassium is <5.0 mmol/L, and eGFR has decreased <30% compared to baseline, the Finerenone dose is adjusted to 40 mg qd. Receives: Drug: Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h systolic BP drop value
The average daytime systolic blood pressure drop from baseline levels after treatment with Finerenone at 12 weeks.
Measured: 12 weeks
Secondary outcomes (7)
The change of diastolic BP from the baseline level after Finerenone treatment
To Clarify the antihypertensive effect of Finerenone by measuring daytime diastolic blood pressure from baseline to the end of treatment .
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Hypertension remission rate
The proportion of patients with SBP<140mmHg and DBP<90mmHg.
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of serum potassium level
Proportion of patients with normal blood potassium levels (serum potassium level ≥ 3.5mmol/L and ≤ 5.5mmol/L).
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of plasma renin activity
to compare plasma renin activity during the progression
Measured: Baseline,4 week,8 weeks,12 weeks,16 weeks
Change of ARR
To see if Finerenone can influence ARR[(ng/dl)/(ng/ml/h)]
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of UACR
Compared to the placebo group, the risk of kidney disease progression in patients with type 2 diabetes and chronic kidney disease decreased by 18% after treatment with nonnarcotic ketones.
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of eGFR
Estimated glomerular filtration rate (eGFR) decline condition.
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Li, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381323
- Sponsor's protocol ID
- PA2024
- Status last verified
- Mar 2024
- First submitted
- 16 Apr 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Publications
Li P, Yang F, Lou Y, Zhang Z, Du Y, Zhang J, Ren Y, Tong A, Xie Z, Shi B, Liu J, Liu L, Zhu D. Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: A Multicenter Prospective Study. Hypertension. 2026 May;83(5):e26048. doi: 10.1161/HYPERTENSIONAHA.125.26048. Epub 2026 Jan 22.
PubMed 41568520
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Clinical Efficacy and Safety of the New Mineralocorticoid Receptor Antagonist Finerenone in the Treatment of Primary Aldosteronism: a Multicenter, Prospective, Open-label Clinical Study
- ClinicalTrials.gov ID
- NCT06381323
- Acronym / sponsor ID
- PA2024
- Keywords
- Primary Aldosteronism, Finerenone, Mineralocorticoid Receptor Antagonist, Hypertension, 24-hour ambulatory blood pressure monitoring, Daytime SBP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism.
Detailed description
Primary aldosteronism(PA) is a clinical syndrome characterized by autonomous aldosterone secretion in the body caused by adrenal cortical adenoma or hyperplasia not regulated by renin, angiotensin II, and sodium status regulation. It is the most common cause of secondary hypertension, accounting for about 10% of all hypertensive patients. The latest prospective study in China showed that the prevalence of primary aldosteronism in newly diagnosed hypertensive patients was 4%, with an additional 3% of suspicious primary aldosteronism patients. Excessive activation of the mineralocorticoid receptor (MR) in the body leads to well-known increased circulating volume overload, hypertension, and hypokalemia, as well as significantly increased cardiovascular, renal, and mortality risks. Therefore, primary aldosteronism is currently considered a new public health problem and has important implications for early diagnosis and precise treatment of primary aldosteronism.
Only about 30% of patients with PA (aldosterone-producing adenoma or unilateral adrenal hyperplasia) can be cured or relieved through surgical resection, while about 65% of patients with primary aldosteronism caused by bilateral adrenal cortical hyperplasia require drug treatment. Currently, the only available drug in China is the first-generation mineralocorticoid receptor antagonist, spironolactone, which is greatly limited in its use due to its significant side effects on the gonads caused by the blockade of androgens and progesterones. Another MRA, eplerenone, which has not yet been marketed in China, is expensive and clinically inferior to spironolactone. Therefore, a large number of patients with primary aldosteronism are currently not using or using low doses of spironolactone, unable to fully counteract the high aldosterone effect, and unable to effectively control the risk of cardiovascular and renal damage. Therefore, it is necessary to explore new drugs for the treatment of primary aldosteronism.
Finerenone is a newly developed novel non-steroidal MRA, which has higher affinity and selectivity for MR binding compared to steroidal MRA (spironolactone or eplerenone). Existing clinical research results suggest that Finerenone can effectively reduce the risk of cardiovascular and renal damage in patients with chronic kidney disease and diabetes, and has good safety.
This study aims to be the first internationally to conduct clinical research on the use of the novel mineralocorticoid receptor antagonist finerenone for the treatment of primary aldosteronism. Through a multicenter, prospective, open-label study, the clinical efficacy and safety of this medication will be clearly established, providing high-level evidence of the use of finerenone in patients with primary aldosteronism. The project's results will offer a new option for the pharmacological treatment of primary aldosteronism, with the goal of better controlling patients' biochemical abnormalities, effectively reducing the risk of cardiovascular and renal damage, and improving disease prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: FinerenoneRecruitment of diagnosed patients with PA from multiple centers, confirmation of subject eligibility according to inclusion criteria and exclusion criteria, and signing of informed consent forms. All eligible subjects enter a 2-week enrollment phase and only take stable doses of controlled-release nifedipine. After completing baseline examinations, subjects with SBP <180 and ≥140 mmHg and DBP <120 and ≥90 mmHg enter the follow-up phase of the treatment period. Eligible subjects receive a starting dose of 20 mg qd of Finerenone. If the blood pressure is still ≥140/90 mmHg at week 4, serum potassium is <5.0 mmol/L, and eGFR has decreased <30% compared to baseline, the Finerenone dose is adjusted to 40 mg qd. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age:18-75 years old.
- History of hypertension, with a sitting SBP ≥140 and <180 mmHg, and a sitting DBP ≥90 and <120 mmHg during the last two evaluations within the observation period.
- Patients with PA who are eligible for drug treatment.
- Diagnostic criteria for primary aldosteronism: (1) Hypertension or use of antihypertensive medications, with or without hypokalemia; (2) Screening test: Baseline plasma aldosterone to renin ratio (ARR) >30 (ng/dl)/(ng/ml/h) or ARR >2.4 (ng/dl)/(mU/L), with plasma aldosterone >15 ng/dl and plasma renin activity <1.0 ng/ml/h; (3) At least one confirmed test is positive: ① After a captopril test, plasma aldosterone decreases by <30% or plasma aldosterone is ≥11 ng/dl, with suppressed renin activity; ② Sitting saline infusion test results in a plasma aldosterone ≥10 ng/dl.
- eGFR ≥60 ml/ (min*1.73m2).
Key exclusion criteria (15 listed)
- Other secondary hypertension (such as renal vascular hypertension, Cushing's syndrome, subclinical Cushing's syndrome, and pheochromocytoma) or hypertensive crisis.
- Orthostatic hypotension.
- Heart failure, acute myocardial infarction, stroke, transient ischemic attack, or other acute cardiovascular events within the past 6 months.
- History of adrenal surgery within the past 6 months.
- History of carotid artery surgery within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneAlso: NifedipineAll eligible subjects enter a 2-week enrollment phase and only take stable doses of controlled-release nifedipine. After completing baseline examinations, subjects with SBP <180 and ≥140 mmHg and DBP <120 and ≥90 mmHg enter the follow-up phase of the treatment period. Eligible subjects receive a starting dose of 20 mg qd of Finerenone. If the blood pressure is still ≥140/90 mmHg at week 4, serum potassium is <5.0 mmol/L, and eGFR has decreased <30% compared to baseline, the Finerenone dose is adjusted to 40 mg qd. | Drug | Finerenone |
Primary outcome
24h systolic BP drop value
Time frame: 12 weeks
The average daytime systolic blood pressure drop from baseline levels after treatment with Finerenone at 12 weeks.
7 secondary outcomes
The change of diastolic BP from the baseline level after Finerenone treatment
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Hypertension remission rate
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of serum potassium level
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of plasma renin activity
Time frame: Baseline,4 week,8 weeks,12 weeks,16 weeks
Change of ARR
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of UACR
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Change of eGFR
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 41568520Li P, Yang F, Lou Y, Zhang Z, Du Y, Zhang J, Ren Y, Tong A, Xie Z, Shi B, Liu J, Liu L, Zhu D. Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: A Multicenter Prospective Study. Hypertension. 2026 May;83(5):e26048. doi: 10.1161/HYPERTENSIONAHA.125.26048. Epub 2026 Jan 22.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
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Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Li study director
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone in people with Primary Aldosteronism and Finerenone, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 15 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 10 Sep 2025. 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?
24h systolic BP drop value (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 NCT06381323, which also lists 1 linked publication.
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 10 Sep 2025.