Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

ConditionsNephropathy Glomerular Diseases Idiopathic Membranous Nephropathy

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 ≥4 weeks before randomization, nephrotic syndrome was not in remission and 24-hour urinary protein level was ≥3.5g/24h and < 8.0g/24h;

Disqualifiers

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%;

Trial design

Design model

Parallel

Treatments tested in this trial

Huaier granule
Drug
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.
Renin-angiotensin-aldosterone system inhibitors (RASI)
Drug
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.
Ciclosporin soft capsules
Drug
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.

Treatment groups

480 Participants

are divided into 2 treatment groups

Group A: Huaier groupExperimental treatment 2 interventions

Group B: Ciclosporin soft capsules groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Overall clinical remission rate at 24, 48, 96 weeks

Overall clinical remission rate is defined as rate of complete remission and partial remission. Complete remission is defined as a 24-h urinary protein level \< 0.3g/d with normal serum albumin level and stable renal function. Partial remission is defined as 24-h urinary protein level \< 3.5g/d with peak value reduction ≥ 50%, accompanied by improved or normal serum albumin, stable renal function.

Time frame