Status:
NOT_YET_RECRUITING
Effect of Finerenone in IgA Nephropathy
Lead Sponsor:
Zhejiang University
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 8 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06580288
Start Date
October 8 2024
End Date
October 8 2026
Last Update
August 30 2024
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