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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06460987
• Other study ID #: KY-2024-081
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases
• Proteinuria
• Safety Issues

Intervention

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

Locations

Country	Name	City	State
China	Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy	Yiwu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage change in PCR from baseline to 6 months	Collect PCR data before enrolment and at month 6 and calculate the percentage change	6 month
Secondary	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	1, 2 and 3 month
Secondary	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	6 month
Secondary	the level of change in eGFR	Collection of eGFR before enrolment and at months 6	6 month
Secondary	the level of change in blood sodium	Collection of blood sodium before enrolment and at months 6	6 month
Secondary	the level of change in serum creatinine	Collection of serum creatinine before enrolment and at months 6	6 month
Secondary	the level of change in albumin	Collection of albumin before enrolment and at months 6	6 month