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

Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study ID
NCT06460987
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 1, 2022
Status verified
Jun 2024
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
245 participants (actual)

Arms

  • Arm: A group: FINE+RASI group;
    Patients treated with RASI and finerenone
  • Arm: B group: RASI group;
    Patients treated with RASI only
  • Arm: C group: immune suppressive + FINE + RASI;
    Patients receiving immunosuppressive drugs and RASIs
  • Arm: D group: immune suppressive + RASI;
    Patients receiving immunosuppressants, RASI and finerenone

Primary Outcome Measure

percentage change in PCR from baseline to 6 months [ Time Frame: 6 month ]

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