Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy

NCT ID: NCT06460987

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-03-31

Brief Summary

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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

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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

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Finerenone IgA Nephropathy Proteinuria Safety Issues

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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A group: FINE+RASI group;

Patients treated with RASI and finerenone

Finerenone

Intervention Type DRUG

Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels

RAS inhibitor

Intervention Type DRUG

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

B group: RASI group;

Patients treated with RASI only

RAS inhibitor

Intervention Type DRUG

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

C group: immune suppressive + FINE + RASI;

Patients receiving immunosuppressive drugs and RASIs

Finerenone

Intervention Type DRUG

Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels

RAS inhibitor

Intervention Type DRUG

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

Immune Suppressant

Intervention Type DRUG

Receive immune suppressant treatment as specified in the KDIGO guidelines

D group: immune suppressive + RASI;

Patients receiving immunosuppressants, RASI and finerenone

RAS inhibitor

Intervention Type DRUG

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

Immune Suppressant

Intervention Type DRUG

Receive immune suppressant treatment as specified in the KDIGO guidelines

Interventions

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Finerenone

Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels

Intervention Type DRUG

RAS inhibitor

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

Intervention Type DRUG

Immune Suppressant

Receive immune suppressant treatment as specified in the KDIGO guidelines

Intervention Type DRUG

Other Intervention Names

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FINE RASI immunosupressive

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiaorui Wang, bachelor

Role: PRINCIPAL_INVESTIGATOR

Student

Locations

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Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy

Yiwu, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40357496 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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KY-2024-081

Identifier Type: -

Identifier Source: org_study_id

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