Study of Huaier Granule Compared to Ciclosporin Capsules for Treating Idiopathic Membranous Nephropathy in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the effects of Huaier granule compared to Ciclosporin soft capsules for treating idiopathic membranous nephropathy IMN, a common immune-related kidney disease causing nephrotic syndrome. This study aims to assess the safety and effectiveness of Huaier granule in adults aged 18 to 75 with IMN, as current treatments like Ciclosporin have notable relapse rates. The trial is a prospective, multicenter, randomized, open-label, parallel controlled study involving about 30 research centers. Participants will be randomly assigned to one of two groups one group will take Huaier granule orally at 10g three times daily for 24 weeks with dose adjustments based on response, combined with renin-angiotensin-aldosterone system inhibitors RASI. The other group will receive Ciclosporin soft capsules starting at 3.5 mgkgday split into two doses, with frequent blood level monitoring and dose adjustments over 24 weeks, also alongside RASI. Both groups continue RASI therapy throughout the study. The recruitment period is planned for 2 years, with total follow-up visits lasting 1 year. During the study, participants will undergo regular assessments including monitoring protein in urine, kidney function tests, antibody levels, and adverse events over 96 weeks. The main outcome is the overall clinical remission rate at 24, 48, and 96 weeks. Additional measures include rates of complete and partial remission, relapse timing, kidney function changes, and safety evaluations. Blood pressure will be tracked twice daily, and medication doses adjusted accordingly. The study investigates long-term outcomes and safety for both treatments in managing IMN.

Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy