Finerenone, IgA Nephropathy, Proteinuria, Safety Issues
Conditions
Keywords
finerenone, IgA Nephropathy
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.
Interventions
DRUGFinerenone
Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels
DRUGRAS inhibitor
Receive RAS inhibitor treatment as specified in the KDIGO guidelines
DRUGImmune Suppressant
Receive immune suppressant treatment as specified in the KDIGO guidelines
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| the level of change in serum creatinine | 6 month | Collection of serum creatinine 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 blood sodium | 6 month | Collection of blood sodium before enrolment and at months 6 |
Countries
China
Outcome results
None listed