Effect of Finerenone in IgA Nephropathy

Last updated: August 28, 2024
Sponsor: Zhejiang University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Nephritis

Nephropathy

Glomerulonephritis

Treatment

Placebo

Finerenone

Clinical Study ID

NCT06580288
IIT20240069C-R1
  • Ages > 18
  • All Genders

Study Summary

The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.

The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgAnephropathy excluded;

  • Age ≥ 18 years;

  • Maximum tolerated dose of RAS inhibitors for more than 3 months, with urinealbumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g; V1 laboratory test showingurine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g. After maximum tolerateddose of RAS inhibitors or ARB, V2 urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g;

  • eGFR calculated by EPI ≥ 30 ml/min/1.73 m²;

  • Serum potassium level ≤ 4.8 mmol/L;

  • SBP ≤ 150 mmHg, DBP ≤ 110 mmHg;

  • LVEF > 40%;

  • Willing and able to provide informed consent.

Exclusion

Exclusion Criteria:

  • There are clear indications for the use of immunosuppressive therapy, such as:nephrotic syndrome (urine protein greater than 3.5 g/d, blood albumin less than 30g/L), pathological minimal change disease combined with IgA nephropathy; theproportion of crescents in kidney biopsy is ≥ 50%.

  • Any existing life-threatening condition with a life expectancy of less than 2 years;

  • Active infection, HBV infection, or active lesions (nodules, cavities, ortuberculomas);

  • AKI causing renal dysfunction;

  • Use of steroids/immunosuppressive drugs within the past 3 months;

  • History of malignant tumors, regardless of treatment status or evidence of localrecurrence or metastasis;

  • Any surgical or medical condition that may significantly alter the absorption,distribution, metabolism, or excretion of the investigational drug;

  • History of drug or alcohol abuse within the past 12 months;

  • History of drug allergies or contraindications;

  • Previous noncompliance or unwillingness to follow the study protocol;

  • Any condition that may affect safety or efficacy;

  • History of kidney transplantation or currently receiving immunosuppressivetreatment;

  • Pregnant or breastfeeding women;

  • Obese patients with a BMI > 35.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 08, 2024
Estimated Completion Date:
October 08, 2026

Study Description

This is a randomized, multicenter, placebo-controlled, double-blind clinical trial aimed at clarifying the safety and efficacy of finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.

Study population will include participants with renal biopsy confirmed IgA nephropathy (eGFR ≥ 30 mL/min/1.73 m2) and UACR ≥500mg/g ≤3500mg/g. Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study.

The study will be conducted at 4 sites. 120 participants will be randomised to one of 2 arms in a 1:1 ratio:

  • Finerenone 10mg/20 mg

  • Placebo 10mg/20 mg For each participant, the total duration of participation will be approximately 12 months.