Huaier granule →Renin-angiotensin-aldosterone system inhibitors (RASI)Ciclosporin soft capsules
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.
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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 ≥4 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;
* 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.
Primary outcome measure(s)
Overall clinical remission rate at 24, 48, 96 weeks — Start of randomization until 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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