Clinical trial NCT06460987: Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy
Official title: Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Finerenone
IgA Nephropathy
Proteinuria
Safety Issues
Keywords: finerenone
IgA Nephropathy
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with IGA nephropathy by renal biopsy who met the inclusion exclusion criteria, were able to be followed up regularly, and had clinical follow-up data.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: percentage change in PCR from baseline to 6 months
timeFrame: 6 month
Secondary outcomes:
measure: percentage change in PCR from baseline to 1, 2 and 3 months
timeFrame: 1, 2 and 3 month
measure: frequency of patients with a 30% and 50% decrease in PCR
timeFrame: 6 month
measure: the level of change in eGFR
timeFrame: 6 month
measure: the level of change in blood sodium
timeFrame: 6 month
measure: the level of change in serum creatinine
timeFrame: 6 month
measure: the level of change in albumin
timeFrame: 6 month
Other outcomes:
Locations:
city: Yiwu
country: China
facility: Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy
state: Zhejiang
Study officials:
affiliation: Student
name: Qiaorui Wang, bachelor
role: PRINCIPAL_INVESTIGATOR
References: