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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Completed

Conditions: Proteinuria; Safety Issues; IgA Nephropathy; Finerenone

Treatments: Drug: RAS inhibitor; Drug: Immune Suppressant; Drug: Finerenone

Study type: Observational

Funder types: Other

Identifiers

NCT06460987

KY-2024-081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

245 participants in 4 patient groups

A group: FINE+RASI group;

Description:

Patients treated with RASI and finerenone

Treatment:

Drug: Finerenone

Drug: RAS inhibitor

B group: RASI group;

Description:

Patients treated with RASI only

Treatment:

Drug: RAS inhibitor

C group: immune suppressive + FINE + RASI;

Description:

Patients receiving immunosuppressive drugs and RASIs

Treatment:

Drug: Finerenone

Drug: Immune Suppressant

Drug: RAS inhibitor

D group: immune suppressive + RASI;

Description:

Patients receiving immunosuppressants, RASI and finerenone

Treatment:

Drug: Immune Suppressant

Drug: RAS inhibitor