Primary AldosteronismPhase 4NCT05924620
Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism
A Phase 4 study testing finerenone in people with Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
Trial summary
To study the efficacy and safety of finerenone in patients with primary aldosteronism Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- finerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2023to 12 Mar 2024
- 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
Inclusion Criteria: Patients who meet the following criterion can be included in this study.
- Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up.
- Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required.
- Aged between 18-70, male or female, with legal capacity.
- eGFR≥60(ml/min/1.73 m2)
- Patients with PA and substandard blood pressure (≥140/90mmHg) who didn't take any antihypertensive drugs or who had been using antihypertensive drugs other than MRA steadily for 2 weeks or more
Exclusion Criteria: Patients with one of the following conditions will be excluded in this study:
- To assess patients with poor compliance who had difficulty fully participating in the study, or who refused to sign written informed consent for the study
- Patients with 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, estimated glomerulus filtration rate<30ml/min/m2
- Patients with serum potassium > 5.0mmol/L without potassium supplementation
- Patients with stroke or acute coronary syndrome within 3 months
- Pregnant or lactating women
- Patients currently receiving sex hormone or glucocorticoid therapy
- Patients with a history of uncontrolled malignant tumor
- Patients who took MRA within 2 weeks
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial
To study the efficacy and safety of finerenone in patients with primary aldosteronism
Read the detailed description
This is a prospective and randomized study involving patients with primary aldosteronism(PA). All paticipants will be randomized into finerenone group(Intervention group) and spironolactone group(Control group) and to compare the antihypertensive effect in patients with PA.
If the self-measured blood pressure of patients at home continues to be greater than 140/90 mmHg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.
- Conditions
- Primary Aldosteronism
- Being tested
- finerenone
- Keywords
- finerenone, spironolactone
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
finerenoneDrug
Also called Kerendia
Patients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd).
| Study group | Role | What they receive |
|---|---|---|
| Patients with PA using finerenone | Experimental | Patients with PA divided into this group need to take finerenone for 60 days (20mg qd) Receives: Drug: finerenone |
| Patients with PA using spironolactone | No intervention | Patients with PA divided into this group need to take spironolactone for 60 days (20mg qd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.
Measured by ambulatory blood pressure monitoring
Measured: At baseline and 2 month of follow-up
Secondary outcomes (2)
Compare the serum potassium elevation in the overall cohort between two groups.
Measured by blood electrolytes
Measured: At baseline and 2 month of follow-up
Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.
Measured by ambulatory blood pressure monitoring
Measured: At baseline and 2 month of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start21 Jun 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
- Investigators
- Qifu Q Li, PhD, Study chair, the Chongqing Primary Aldosteronism Study (CONPASS) Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924620
- Sponsor's protocol ID
- Finerenone study
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05924620
- Acronym / sponsor ID
- Finerenone study
- Conditions
- Primary Aldosteronism
- Keywords
- finerenone, spironolactone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 29 Jun 2023 (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.
To study the efficacy and safety of finerenone in patients with primary aldosteronism
Detailed description
This is a prospective and randomized study involving patients with primary aldosteronism(PA). All paticipants will be randomized into finerenone group(Intervention group) and spironolactone group(Control group) and to compare the antihypertensive effect in patients with PA.
If the self-measured blood pressure of patients at home continues to be greater than 140/90 mmHg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PA using finerenone | Experimental | Drug: finerenonePatients with PA divided into this group need to take finerenone for 60 days (20mg qd) |
| Patients with PA using spironolactone | No intervention | –Patients with PA divided into this group need to take spironolactone for 60 days (20mg qd) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: KerendiaPatients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd). | Drug | Patients with PA using finerenone |
Primary outcome
Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.
Time frame: At baseline and 2 month of follow-up
Measured by ambulatory blood pressure monitoring
2 secondary outcomes
Compare the serum potassium elevation in the overall cohort between two groups.
Time frame: At baseline and 2 month of follow-up
Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.
Time frame: At baseline and 2 month of follow-up
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 18 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Qifu Q Li, PhD study chair
the Chongqing Primary Aldosteronism Study (CONPASS) Group
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, run by Chongqing Medical University 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?
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 18 Jun 2024. 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?
Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups. (time frame: At baseline and 2 month of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2024.