Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

• Status: Not yet recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multicenter, randomized, open-label, parallel controlled study. The purpose of this study is to evaluate the efficacy and safety of Huaier granule on the treatment of idiopathic membranous nephropathy comparing with Ciclosporin soft capsules.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Collaborators: Huazhong University of Science and Technology; LinkDoc Technology (Beijing) Co. Ltd.
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Renal biopsy was performed before randomization and pathologically diagnosed as idiopathic membranous nephropathy;

• Anti-phospholipase a2 receptor (PLA2R) antibody is positive;

• Aged from 18 to 75, either sex;

• Tolerable doses of RASI were received for ≥12 weeks before randomization, nephrotic syndrome was not in remission and 24-hour urinary protein level was ≥3.5g/24h and < 8.0g/24h;

• The eGFR≥45ml/min/1.73m2 (Measured at least twice in 2 weeks);

• The patient is willing to sign the informed consent form.

Exclusion Criteria:

• Diagnosed as secondary membranous nephropathy;

• Rapidly progressive membranous nephropathy (eGFR decreased by 50 % compared with the baseline level within 3 months);

• Receiving renal replacement therapy;

• Diabetes and glycosylated hemoglobin (HbA1c) levels ≥ 7.0%;

• Hypertension is not well controlled (systolic blood pressure>160mmHg or diastolic blood pressure>100mmHg);

• The level of serum albumin≤20g/L;

• History of resistance to treatment with CsA or other CNI, rituximab (RTX) or alkylating agents; complete remission or partial remission was obtained after treatment with CNI, RTX, or alkylating agents but there was a history of relapse within 3 months；

• Suspected infection by imaging and/or laboratory tests;

• Infectious diseases, such as hepatitis B, hepatitis C, AIDS, tuberculosis;

• History of malignant tumor;

• Hepatic dysfunction: aspartate aminotransferase (AST) concentration and alanine aminotransferase (ALT) concentration of > 1.5 × upper limit of normal;

• Allergic to Huaier granule or Ciclosporin soft capsules;

• Previous CNI treatment was ineffective;

• Complicate with any diseases that may affect efficacy and safety evaluation;

• Pregnant or lactating women, and patients (male or female) with fertility plans or unwilling to take effective contraceptive measures;

• Participating in other clinical trials or participated in other clinical studies within 3 months;

• According to the researchers, patients have diseases or conditions that increase the difficulty of enrollment or probability of loss to follow-up, such as mental illness, frequent changes in residence and work, etc.