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

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.

Study Overview

• Status: Completed
• Conditions: Proteinuria; IgA Nephropathy; Safety Issues; Finerenone
• Intervention / Treatment: Drug: Finerenone; Drug: RAS inhibitor; Drug: Immune Suppressant

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.

• Study Type: Observational
• Enrollment (Actual): 245

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China
      • Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A group: FINE+RASI group; Patients treated with RASI and finerenone	Drug: Finerenone; Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels; Other Names: FINE; Drug: RAS inhibitor; Receive RAS inhibitor treatment as specified in the KDIGO guidelines; Other Names: RASI
B group: RASI group; Patients treated with RASI only	Drug: RAS inhibitor; Receive RAS inhibitor treatment as specified in the KDIGO guidelines; Other Names: RASI
C group: immune suppressive + FINE + RASI; Patients receiving immunosuppressive drugs and RASIs	Drug: Finerenone; Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels; Other Names: FINE; Drug: RAS inhibitor; Receive RAS inhibitor treatment as specified in the KDIGO guidelines; Other Names: RASI; Drug: Immune Suppressant; Receive immune suppressant treatment as specified in the KDIGO guidelines; Other Names: immunosupressive
D group: immune suppressive + RASI; Patients receiving immunosuppressants, RASI and finerenone	Drug: RAS inhibitor; Receive RAS inhibitor treatment as specified in the KDIGO guidelines; Other Names: RASI; Drug: Immune Suppressant; Receive immune suppressant treatment as specified in the KDIGO guidelines; Other Names: immunosupressive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
the level of change in eGFR	Collection of eGFR before enrolment and at months 6	6 month
the level of change in blood sodium	Collection of blood sodium before enrolment and at months 6	6 month
the level of change in serum creatinine	Collection of serum creatinine before enrolment and at months 6	6 month
the level of change in albumin	Collection of albumin before enrolment and at months 6	6 month

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Qiaorui Wang, bachelor, Student

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: IgA Nephropathy; finerenone
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Urological Manifestations; Urination Disorders; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Proteinuria; Glomerulonephritis, IGA; Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: KY-2024-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No