NCT06580288

Effect of Finerenone in IgA Nephropathy

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Finerenone in the Treatment of IgA Nephropathy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Finerenone	10mg or 20mg
DRUG	Placebo	10mg or 20mg

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-06-08
• Completion: 2026-10-08
• First posted: 2024-08-30
• Last updated: 2024-08-30