Huaier granule treatment for idiopathic membranous nephropathy

Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy: a Multicenter, Randomized, Open-label, Parallel Controlled Study

This study is testing if Huaier granules can be a safe and effective treatment for people with idiopathic membranous nephropathy who haven't responded well to standard medications.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: rituximab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05839314 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Huaier granule compared to Ciclosporin soft capsules in treating idiopathic membranous nephropathy (IMN). It is a multicenter, randomized, open-label, parallel controlled study involving approximately 480 participants across 30 research centers. Participants will be monitored over a total duration of one year, with a focus on measuring proteinuria levels and renal function. The study aims to provide insights into a potential alternative treatment for patients with IMN who are resistant to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of idiopathic membranous nephropathy and specific proteinuria levels.

Not a fit: Patients with secondary membranous nephropathy or those requiring renal replacement therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients suffering from idiopathic membranous nephropathy.

How similar studies have performed: Previous studies have shown promising results for Huaier granule in reducing proteinuria and protecting renal function, suggesting potential success for this approach.

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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA general hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xiangmei Chen, PhD — Chinese PLA General Hospital, Beijing, China
• Study coordinator: Xiangmei Chen, PhD

Conditions Nephropathy; Glomerular Diseases; Idiopathic Membranous Nephropathy; Huaier granule; Ciclosporin; Idiopathic membranous nephropathy