Actively Recruiting
Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy
Led by Chinese PLA General Hospital · Updated on 2024-06-04
480
Participants Needed
1
Research Sites
216 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
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
Official Title
Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Renal biopsy diagnosed idiopathic membranous nephropathy before randomization
- Positive anti-phospholipase a2 receptor (PLA2R) antibody
- Aged 18 to 75 years, any gender
- Received tolerable doses of RASI for at least 4 weeks before randomization
- Nephrotic syndrome not in remission with 24-hour urinary protein between 3.5 and less than 8.0 g/24h
- Estimated glomerular filtration rate (eGFR) of at least 45 ml/min/1.73m2 measured twice within 2 weeks
- Willing to sign informed consent
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 HbA1c level 7.0% or higher
- Poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Serum albumin level below 20 g/L
- Resistance to treatment with Ciclosporin, other CNIs, rituximab, or alkylating agents
- Complete or partial remission after prior treatment but relapse within 3 months
- Suspected infection by imaging or lab tests
- Infectious diseases such as hepatitis B, hepatitis C, AIDS, or tuberculosis
- History of cancer
- Liver dysfunction with AST or ALT more than 1.5 times the upper limit of normal
- Allergy to Huaier granule or Ciclosporin soft capsules
- Previous ineffective CNI treatment
- Other diseases affecting safety or treatment evaluation
- Pregnant or breastfeeding women, or patients planning pregnancy or unwilling to use contraception
- Participation in other clinical trials within 3 months
- Conditions increasing enrollment difficulty or loss to follow-up such as mental illness or frequent residence/work changes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA general hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xiangmei Chen, PhD
CONTACT
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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