NCT06460987

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 245 (actual)
• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Finerenone
• IgA Nephropathy
• Proteinuria
• Safety Issues

Interventions

Type	Name	Description
DRUG	Finerenone	Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels
DRUG	RAS inhibitor	Receive RAS inhibitor treatment as specified in the KDIGO guidelines
DRUG	Immune Suppressant	Receive immune suppressant treatment as specified in the KDIGO guidelines

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2024-06-14
• Last updated: 2024-06-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study