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NCT Number: NCT06460987

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Finerenone

Drug

Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels

Other names: FINE

RAS inhibitor

Drug

Receive RAS inhibitor treatment as specified in the KDIGO guidelines

Other names: RASI

Immune Suppressant

Drug

Receive immune suppressant treatment as specified in the KDIGO guidelines

Other names: immunosupressive

Primary outcomes

  1. percentage change in PCR from baseline to 6 months

    Time frame: 6 month

    Collect PCR data before enrolment and at month 6 and calculate the percentage change

Secondary outcomes

  1. percentage change in PCR from baseline to 1, 2 and 3 months

    Time frame: 1, 2 and 3 month

    Collec PCR before enrolment and at months 1, 2 and 3, then calculate the percentage change

  2. frequency of patients with a 30% and 50% decrease in PCR

    Time frame: 6 month

    Calculate the number of patients with >30% or >50% reduction in proteinuria during the 6-month follow-up period

  3. the level of change in eGFR

    Time frame: 6 month

    Collection of eGFR before enrolment and at months 6

  4. the level of change in blood sodium

    Time frame: 6 month

    Collection of blood sodium before enrolment and at months 6

  5. the level of change in serum creatinine

    Time frame: 6 month

    Collection of serum creatinine before enrolment and at months 6

  6. the level of change in albumin

    Time frame: 6 month

    Collection of albumin before enrolment and at months 6

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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