Effect of Finerenone in IgA Nephropathy

Launched by ZHEJIANG UNIVERSITY · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Finerenone to see if it can help patients with a kidney condition known as IgA nephropathy. The goal is to find out if Finerenone can reduce protein in the urine and protect kidney function over a period of 12 months. Participants will be randomly assigned to receive either Finerenone or a placebo, which is a dummy pill that looks the same but has no active medication.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of IgA nephropathy within the last two years. They should have certain levels of protein in their urine and have been treated with maximum doses of specific blood pressure medications for at least three months. Participants will need to provide informed consent and be able to attend regular check-ups during the study. It’s important to know that some individuals, such as those with certain serious health conditions or those currently on specific medications, may not qualify for this trial. If you or someone you know is interested, please reach out for more information as the study is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgA nephropathy excluded;
• • Age ≥ 18 years;
• • Maximum tolerated dose of RAS inhibitors for more than 3 months, with urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g; V1 laboratory test showing urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g. After maximum tolerated dose 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 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 30 g/L), pathological minimal change disease combined with IgA nephropathy; the proportion 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, or tuberculomas);
• • 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 local recurrence 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 immunosuppressive treatment;
• • Pregnant or breastfeeding women;
• • Obese patients with a BMI \> 35.