Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

PHASE4RecruitingINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

May 9, 2023

Primary Completion Date

May 3, 2027

Study Completion Date

July 1, 2027

Conditions
NephropathyGlomerular DiseasesIdiopathic 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."

Trial Locations (1)

Unknown

RECRUITING

Chinese PLA general hospital, Beijing

All Listed Sponsors
collaborator

LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

collaborator

Huazhong University of Science and Technology

OTHER

lead

Chinese PLA General Hospital

OTHER