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

Completed

• Conditions: Finerenone; IgA Nephropathy; Proteinuria; Safety Issues
• Interventions: Drug: Finerenone; Drug: RAS inhibitor; Drug: Immune Suppressant

• Registration Number: NCT06460987
• Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Brief 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. 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 Timeline

• Study Start: 2022-12-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Study First Submitted: 2024-05-28
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C group: immune suppressive + FINE + RASI;	RAS inhibitor	Patients receiving immunosuppressive drugs and RASIs
D group: immune suppressive + RASI;	RAS inhibitor	Patients receiving immunosuppressants, RASI and finerenone
B group: RASI group;	RAS inhibitor	Patients treated with RASI only
A group: FINE+RASI group;	RAS inhibitor	Patients treated with RASI and finerenone
C group: immune suppressive + FINE + RASI;	Immune Suppressant	Patients receiving immunosuppressive drugs and RASIs
D group: immune suppressive + RASI;	Immune Suppressant	Patients receiving immunosuppressants, RASI and finerenone
A group: FINE+RASI group;	Finerenone	Patients treated with RASI and finerenone
C group: immune suppressive + FINE + RASI;	Finerenone	Patients receiving immunosuppressive drugs and RASIs

Primary Outcome Measures

Name	Time	Method
percentage change in PCR from baseline to 6 months	6 month	Collect PCR data before enrolment and at month 6 and calculate the percentage change

Secondary Outcome Measures

Name	Time	Method
the level of change in blood sodium	6 month	Collection of blood sodium before enrolment and at months 6
percentage change in PCR from baseline to 1, 2 and 3 months	1, 2 and 3 month	Collec PCR before enrolment and at months 1, 2 and 3, then calculate the percentage change
frequency of patients with a 30% and 50% decrease in PCR	6 month	Calculate the number of patients with \>30% or \>50% reduction in proteinuria during the 6-month follow-up period
the level of change in eGFR	6 month	Collection of eGFR before enrolment and at months 6
the level of change in albumin	6 month	Collection of albumin before enrolment and at months 6
the level of change in serum creatinine	6 month	Collection of serum creatinine before enrolment and at months 6

Trial Locations

Locations (1)

Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy; 🇨🇳 Yiwu, Zhejiang, China