Effect of Finerenone in IgA Nephropathy
ConditionIgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Finerenone
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov