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CompletedNCT05924620Updated Jun 18, 2024

Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

A Phase 4 interventional study of finerenone in Primary Aldosteronism, sponsored by Chongqing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Chongqing Medical University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2024, 2 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Primary Aldosteronism

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Keywords

  • finerenone
  • spironolactone
03

In context

Hyperaldosteronism

193 studies on the registry are indexed under Hyperaldosteronism; 89 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 91 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Chongqing Medical University is the lead sponsor of 75 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Patients who meet the following criterion can be included in this study.

  1. Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up.
  2. Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required.
  3. Aged between 18-70, male or female, with legal capacity.
  4. eGFR≥60(ml/min/1.73 m2)
  5. 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:

  1. 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
  2. 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
  3. Patients with serum potassium > 5.0mmol/L without potassium supplementation
  4. Patients with stroke or acute coronary syndrome within 3 months
  5. Pregnant or lactating women
  6. Patients currently receiving sex hormone or glucocorticoid therapy
  7. Patients with a history of uncontrolled malignant tumor
  8. Patients who took MRA within 2 weeks
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Patients with PA using finerenone

    Patients with PA divided into this group need to take finerenone for 60 days (20mg qd)

    Drug: finerenone

  • No intervention
    Patients with PA using spironolactone

    Patients with PA divided into this group need to take spironolactone for 60 days (20mg qd)

Interventions

  • Drugfinerenone

    Patients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd).

    Also known as: Kerendia

06

What researchers measure

Primary outcomes

  1. Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.

    Measured by ambulatory blood pressure monitoring

    Time frame: At baseline and 2 month of follow-up

Secondary outcomes

  1. Compare the serum potassium elevation in the overall cohort between two groups.

    Measured by blood electrolytes

    Time frame: At baseline and 2 month of follow-up

  2. Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.

    Measured by ambulatory blood pressure monitoring

    Time frame: At baseline and 2 month of follow-up

07

Study locations

1 site
  • The First Affilated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400016, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05924620
Lead sponsor
Chongqing Medical University
Responsible party
Qifu Li (Professor.Qifu Li, Chongqing Medical University) — Principal investigator
First posted
Jun 29, 2023
Start date
Jun 21, 2023
Primary completion
Mar 12, 2024
Completion
Mar 12, 2024
Last update
Jun 18, 2024

Study contacts

Qifu Q Li, PhD
study chair · the Chongqing Primary Aldosteronism Study (CONPASS) Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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