FinerenoneNCT06460987
Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy
An observational study of Finerenone and IgA Nephropathy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Finerenone, IgA Nephropathy, Proteinuria
- What is being tested?
- Finerenone, RAS inhibitor and Immune Suppressant
- How many people
- 245 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Mar 2024
- Phase
- Observational
- 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
Study population: Patients diagnosed with IGA nephropathy by renal biopsy who met the inclusion exclusion criteria, were able to be followed up regularly, and had clinical follow-up data.
Who may be able to join
- primary IgAN diagnosed by renal biopsy;
- receive RASI inhibitors for at least 3 months;
- serum potassium <5 mmol/L;
- protein-to-creatinine ratio (PCR) >0.3 mg/g
Who cannot join
- secondary IgAN;
- autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, lupus nephritis,;
- previous renal transplantation;
- chronic hepatic disease, malignant tumor, active malignancy, heart failure with ejection fraction <40%;
- followed up less than 6 months;
Trial locations and contacts
1 site in 1 country.
China1 site
Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy
Yiwu, Zhejiang
About this study
Official title: Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA
IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
Read the detailed description
Primary IgA nephropathy (IgAN) is an immunopathological diagnostic term for a type of glomerulonephritis characterised by the deposition of IgA or IgA-dominant immune complexes in the glomerular tunica albuginea. And in China IgA nephropathy accounts for about 45% of primary glomerular diseases and about 26% of renal biopsies in patients with chronic failure. Among them, about 15-40% of IgA nephropathy patients progress to renal failure after 10-20 years; IgA nephropathy has become one of the main causes of end-stage renal failure.The nonsteroidal salicorticoid receptor antagonist (MRA)- finerenone reduces the risk of composite renal outcomes, ESKD, or renal death in patients with type 2 diabetes and CKD.There are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
- Conditions
- Finerenone, IgA Nephropathy, Proteinuria, Safety Issues
- Being tested
- Finerenone, RAS inhibitor, Immune Suppressant
- Keywords
- finerenone, IgA Nephropathy
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Also called FINE
Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels
RAS inhibitorDrug
Also called RASI
Receive RAS inhibitor treatment as specified in the KDIGO guidelines
Immune SuppressantDrug
Also called immunosupressive
Receive immune suppressant treatment as specified in the KDIGO guidelines
| Study group | Role | What they receive |
|---|---|---|
| A group: FINE+RASI group; | Patients treated with RASI and finerenone Receives: Drug: Finerenone; Drug: RAS inhibitor | |
| B group: RASI group; | Patients treated with RASI only Receives: Drug: RAS inhibitor | |
| C group: immune suppressive + FINE + RASI; | Patients receiving immunosuppressive drugs and RASIs Receives: Drug: Finerenone; Drug: RAS inhibitor; Drug: Immune Suppressant | |
| D group: immune suppressive + RASI; | Patients receiving immunosuppressants, RASI and finerenone Receives: Drug: RAS inhibitor; Drug: Immune Suppressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change in PCR from baseline to 6 months
Collect PCR data before enrolment and at month 6 and calculate the percentage change
Measured: 6 month
Secondary outcomes (6)
percentage change in PCR from baseline to 1, 2 and 3 months
Collec PCR before enrolment and at months 1, 2 and 3, then calculate the percentage change
Measured: 1, 2 and 3 month
frequency of patients with a 30% and 50% decrease in PCR
Calculate the number of patients with >30% or >50% reduction in proteinuria during the 6-month follow-up period
Measured: 6 month
the level of change in eGFR
Collection of eGFR before enrolment and at months 6
Measured: 6 month
the level of change in blood sodium
Collection of blood sodium before enrolment and at months 6
Measured: 6 month
the level of change in serum creatinine
Collection of serum creatinine before enrolment and at months 6
Measured: 6 month
the level of change in albumin
Collection of albumin before enrolment and at months 6
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Dec 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
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 FinerenoneStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiaorui Wang, bachelor, Principal investigator, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460987
- Sponsor's protocol ID
- KY-2024-081
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang QR, Wu L, Huang J, Pan H, Wang XF, Li L, Han F, Wang YF, Wu ML, Yang Y. Efficacy and safety of finerenone in IgA nephropathy: an observational multicentre study. Clin Kidney J. 2025 Apr 28;18(5):sfaf125. doi: 10.1093/ckj/sfaf125. eCollection 2025 May.
PubMed 40357496
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA
- ClinicalTrials.gov ID
- NCT06460987
- Acronym / sponsor ID
- KY-2024-081
- Conditions
- Finerenone, IgA Nephropathy, Proteinuria, Safety Issues
- Keywords
- finerenone, IgA Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 14 Jun 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.
IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
Detailed description
Primary IgA nephropathy (IgAN) is an immunopathological diagnostic term for a type of glomerulonephritis characterised by the deposition of IgA or IgA-dominant immune complexes in the glomerular tunica albuginea. And in China IgA nephropathy accounts for about 45% of primary glomerular diseases and about 26% of renal biopsies in patients with chronic failure. Among them, about 15-40% of IgA nephropathy patients progress to renal failure after 10-20 years; IgA nephropathy has become one of the main causes of end-stage renal failure.The nonsteroidal salicorticoid receptor antagonist (MRA)- finerenone reduces the risk of composite renal outcomes, ESKD, or renal death in patients with type 2 diabetes and CKD.There are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A group: FINE+RASI group; | – | Drug: Finerenone, Drug: RAS inhibitorPatients treated with RASI and finerenone |
| B group: RASI group; | – | Drug: RAS inhibitorPatients treated with RASI only |
| C group: immune suppressive + FINE + RASI; | – | Drug: Finerenone, Drug: RAS inhibitor, Drug: Immune SuppressantPatients receiving immunosuppressive drugs and RASIs |
| D group: immune suppressive + RASI; | – | Drug: RAS inhibitor, Drug: Immune SuppressantPatients receiving immunosuppressants, RASI and finerenone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IGA nephropathy by renal biopsy who met the inclusion exclusion criteria, were able to be followed up regularly, and had clinical follow-up data.
Key inclusion criteria (4 listed)
- primary IgAN diagnosed by renal biopsy;
- receive RASI inhibitors for at least 3 months;
- serum potassium <5 mmol/L;
- protein-to-creatinine ratio (PCR) >0.3 mg/g
Key exclusion criteria (5 listed)
- secondary IgAN;
- autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, lupus nephritis,;
- previous renal transplantation;
- chronic hepatic disease, malignant tumor, active malignancy, heart failure with ejection fraction <40%;
- followed up less than 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: FINETaking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels | Drug | A group: FINE+RASI group;, C group: immune suppressive + FINE + RASI; |
| RAS inhibitorAlso: RASIReceive RAS inhibitor treatment as specified in the KDIGO guidelines | Drug | A group: FINE+RASI group;, B group: RASI group;, C group: immune suppressive + FINE + RASI;, D group: immune suppressive + RASI; |
| Immune SuppressantAlso: immunosupressiveReceive immune suppressant treatment as specified in the KDIGO guidelines | Drug | C group: immune suppressive + FINE + RASI;, D group: immune suppressive + RASI; |
Primary outcome
percentage change in PCR from baseline to 6 months
Time frame: 6 month
Collect PCR data before enrolment and at month 6 and calculate the percentage change
6 secondary outcomes
percentage change in PCR from baseline to 1, 2 and 3 months
Time frame: 1, 2 and 3 month
frequency of patients with a 30% and 50% decrease in PCR
Time frame: 6 month
the level of change in eGFR
Time frame: 6 month
the level of change in blood sodium
Time frame: 6 month
the level of change in serum creatinine
Time frame: 6 month
the level of change in albumin
Time frame: 6 month
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 14 Jun 2024.
- Derived from this study: PubMed 40357496Wang QR, Wu L, Huang J, Pan H, Wang XF, Li L, Han F, Wang YF, Wu ML, Yang Y. Efficacy and safety of finerenone in IgA nephropathy: an observational multicentre study. Clin Kidney J. 2025 Apr 28;18(5):sfaf125. doi: 10.1093/ckj/sfaf125. eCollection 2025 May.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
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RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Not yet recruitingObservational study
A Study to Learn More About How Well Finerenone Works in Real-world in People With Type 2 Diabetes and Chronic Kidney Disease in Primary Care (IMSS= Instituto Mexicano Del Seguro Social)
Type 2 Diabetes, Chronic Kidney Disease (CKD) Stages G2 to G3b
Active, not recruitingObservational study
A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
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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.
Qiaorui Wang, bachelor principal investigator
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Finerenone and IgA Nephropathy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 4 inclusion and 5 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 14 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.
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?
percentage change in PCR from baseline to 6 months (time frame: 6 month). 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 NCT06460987, 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 14 Jun 2024.