NCT05839314 Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy
| NCT ID | NCT05839314 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2027-05-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 480 participants in total. It began in 2023-05-09 with a primary completion date of 2027-05-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Xiangmei Chen, PhD
PRINCIPAL INVESTIGATOR
Chinese PLA General Hospital, Beijing, China
Frequently Asked Questions
Who can join the NCT05839314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05839314 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05839314 currently recruiting?
Yes, NCT05839314 is actively recruiting participants. Contact the research team at shengdai26@163.com for enrollment information.
Where is the NCT05839314 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05839314 clinical trial?
NCT05839314 is sponsored by Chinese PLA General Hospital. The principal investigator is Xiangmei Chen, PhD at Chinese PLA General Hospital, Beijing, China. The trial plans to enroll 480 participants.