Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

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.

Conditions

• Nephropathy
• Glomerular Diseases
• Idiopathic Membranous Nephropathy

Interventions

DRUG

Huaier granule

Huaier granule, oral administration, 10g each time, 3 times a day, continuous medication for 24 weeks. After 24 weeks of treatment, the dosage should be adjusted according to efficacy.

DRUG

Renin-angiotensin-aldosterone system inhibitors (RASI)

Run-in period: All the patients should be treated with RASI for at least 4 weeks, and stop using any medicine containing Huaier or similar ingredients for at least 2 weeks before enrollment. If the patient is receiving RASI, the RASI can be continued until the end of the study. RASI can be adjusted once a week until the maximum tolerable dose based on albuminuria and blood pressure. If the patient is not receiving RASI therapy, then RASI is recommended. Treatment period: RASI therapy is continued throughout the trial. Check blood pressure twice daily: morning and evening.

DRUG

Ciclosporin soft capsules

The initial dose of Ciclosporin soft capsules is an oral dose of 3.5mg/kg/d, divided into two equal doses, given every 12 hours. Assess the plasma concentration of CsA (valley value) every 2 weeks in the first 8 weeks. If the plasma concentration of CsA reaches 100-150ug/L, continue to maintain the dose. If the plasma concentration of CsA is below the target concentration, increase the dose of CsA. If the plasma concentration of CsA is higher than the upper limit of the target concentration, appropriate dose reduction. A single dose adjustment is 25mg/d. After increasing/decreasing the dose, CsA concentration is remeasured at intervals of 2 weeks ±3 days until the target concentration is reached. CsA at target concentration followed by 24 weeks of treatment, then the dosage shall be adjusted according to efficacy.

Sponsors & Collaborators

• LinkDoc Technology (Beijing) Co. Ltd.

  collaborator INDUSTRY

• Huazhong University of Science and Technology

  collaborator OTHER

• Chinese PLA General Hospital

  lead OTHER

Principal Investigators

• Xiangmei Chen, PhD · Chinese PLA General Hospital, Beijing, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-09

Primary Completion

2027-05-03

Completion

2027-07-01

Countries

• China

Study Locations