Actively Recruiting
Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy: a Multicenter, Randomized, Open-label, Parallel Controlled Study
Led by Chinese PLA General Hospital · Updated on 2024-06-04
480
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
L
LinkDoc Technology (Beijing) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Huaier granule compared to Ciclosporin soft capsules for treating idiopathic membranous nephropathy (IMN), a common immune-related kidney disease causing nephrotic syndrome. This study aims to assess the safety and effectiveness of Huaier granule in adults aged 18 to 75 with IMN, as current treatments like Ciclosporin have notable relapse rates. The trial is a prospective, multicenter, randomized, open-label, parallel controlled study involving about 30 research centers. Participants will be randomly assigned to one of two groups: one group will take Huaier granule orally at 10g three times daily for 24 weeks with dose adjustments based on response, combined with renin-angiotensin-aldosterone system inhibitors (RASI). The other group will receive Ciclosporin soft capsules starting at 3.5 mg/kg/day split into two doses, with frequent blood level monitoring and dose adjustments over 24 weeks, also alongside RASI. Both groups continue RASI therapy throughout the study. The recruitment period is planned for 2 years, with total follow-up visits lasting 1 year. During the study, participants will undergo regular assessments including monitoring protein in urine, kidney function tests, antibody levels, and adverse events over 96 weeks. The main outcome is the overall clinical remission rate at 24, 48, and 96 weeks. Additional measures include rates of complete and partial remission, relapse timing, kidney function changes, and safety evaluations. Blood pressure will be tracked twice daily, and medication doses adjusted accordingly. The study investigates long-term outcomes and safety for both treatments in managing IMN.
CONDITIONS
Brief Title
Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Renal biopsy confirmed idiopathic membranous nephropathy
- Positive anti-phospholipase a2 receptor (PLA2R) antibody
- Aged 18 to 75 years, any sex
- Receiving tolerable doses of renin-angiotensin-aldosterone system inhibitors (RASI) for at least 4 weeks before randomization
- Nephrotic syndrome not in remission with 24-hour urinary protein between 3.5g and less than 8.0g
- Estimated glomerular filtration rate (eGFR) 45 ml/min/1.73m2 or higher, measured at least twice within 2 weeks
- Willing to sign informed consent form
You will not qualify if you...
- Diagnosed with secondary membranous nephropathy
- Rapidly progressive membranous nephropathy with eGFR decrease of 50% within 3 months
- Receiving renal replacement therapy
- Diabetes with glycosylated hemoglobin (HbA1c) 7.0% or higher
- Uncontrolled hypertension with systolic blood pressure above 160 mmHg or diastolic above 100 mmHg
- Serum albumin level 20 g/L or lower
- Resistance to ciclosporin or other calcineurin inhibitors, rituximab, or alkylating agents
- Complete or partial remission after prior treatments but relapsed within 3 months
- Suspected infection by imaging or laboratory tests
- Infectious diseases including hepatitis B, hepatitis C, AIDS, or tuberculosis
- History of malignant tumor
- Hepatic dysfunction with AST or ALT above 1.5 times upper normal limit
- Allergy to Huaier granule or ciclosporin soft capsules
- Previous ineffective calcineurin inhibitor treatment
- Any disease affecting treatment evaluation or safety
- Pregnant, lactating, or planning pregnancy without effective contraception
- Participating in other clinical trials or studies within 3 months
- Conditions increasing enrollment difficulty or risk of loss to follow-up such as mental illness or frequent residence changes
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 4 weeks
Participants receive treatment with renin-angiotensin-aldosterone system inhibitors (RASI) for at least 4 weeks before randomization. Adjustment of RASI dose may occur weekly based on albuminuria and blood pressure.
Weekly visits for dose adjustment
Duration - 24 weeks
Participants receive assigned treatments: either Huaier granule orally three times daily for 24 weeks combined with continued RASI therapy, or Ciclosporin soft capsules dosed every 12 hours for 24 weeks combined with continued RASI therapy. Ciclosporin plasma concentration is monitored every 2 weeks during the first 8 weeks for dose adjustments. Blood pressure is checked twice daily throughout the treatment.
Biweekly visits for Ciclosporin monitoring (if applicable), regular visits for Huaier group as per protocol
Duration - Up to 72 weeks after treatment
Participants are monitored for clinical remission, relapse, and safety outcomes up to 96 weeks from randomization after treatment ends.
Visits at 24, 48, and 96 weeks post-randomization
Trial Site Locations
Total: 1 location
1
Chinese PLA general hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xiangmei Chen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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