An observational study in Finerenone, IgA Nephropathy and Proteinuria, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Observational
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 245 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 90 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients treated with RASI and finerenone
Drug: Finerenone · Drug: RAS inhibitor
Patients treated with RASI only
Drug: RAS inhibitor
Patients receiving immunosuppressive drugs and RASIs
Drug: Finerenone · Drug: RAS inhibitor · Drug: Immune Suppressant
Patients receiving immunosuppressants, RASI and finerenone
Drug: RAS inhibitor · Drug: Immune Suppressant
Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels
Also known as: FINE
Receive RAS inhibitor treatment as specified in the KDIGO guidelines
Also known as: RASI
Receive immune suppressant treatment as specified in the KDIGO guidelines
Also known as: immunosupressive
percentage change in PCR from baseline to 6 months
Collect PCR data before enrolment and at month 6 and calculate the percentage change
Time frame: 6 month
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
Time frame: 1, 2 and 3 month
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
Time frame: 6 month
the level of change in eGFR
Collection of eGFR before enrolment and at months 6
Time frame: 6 month
the level of change in blood sodium
Collection of blood sodium before enrolment and at months 6
Time frame: 6 month
the level of change in serum creatinine
Collection of serum creatinine before enrolment and at months 6
Time frame: 6 month
the level of change in albumin
Collection of albumin before enrolment and at months 6
Time frame: 6 month
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Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine