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Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

StatusRecruiting
PhasePhase 4
Started2023-05-09
View on ClinicalTrials.gov ↗

Amendment history

2024-06-02
Study Status, Arms and Interventions, Eligibility v3
Primary completion date2025-12-31→2027-05-03
Completion date2026-06-30→2027-07-01
Eligibility criteria-12 characters
[...] 75, either sex; Tolerable doses of RASI were received for ≥124 weeks before randomization, nephrotic syndrome was not in r [...] blood pressure>100mmHg); The level of serum albumin≤20g/L; History of resistanceResistance to treatment with CsA or other CNI, rituximab (RTX) or alky [...]
2023-12-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06-01→confirmed 2023-05-09
Study sites0→1
2023-05-04
Study Status v1
Primary completion date2023-05-31→2025-12-31
Completion date2026-01-31→2026-06-30
Start date2023-04-30→2023-06-01
2023-04-20
Original filing
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.
Trial Details
NCT Number NCT05839314
Lead Sponsor Chinese PLA General Hospital
Collaborators: LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
Conditions Nephropathy, Glomerular Diseases, Idiopathic Membranous Nephropathy
Enrollment 480 participants
Start Date 2023-05-09
Primary Completion 2027-05-03 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2024-06-04