Effect of Huaier Granule on the Treatment of 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
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
Treatments tested in this trial
- Huaier granule
- Renin-angiotensin-aldosterone system inhibitors (RASI)
- Ciclosporin soft capsules
Treatment groups
480 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov