Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy

Launched by CHINESE PLA GENERAL HOSPITAL · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Huaier granule for people with idiopathic membranous nephropathy, a type of kidney disease. The study will compare how effective and safe Huaier granule is compared to Ciclosporin soft capsules, another medication used for this condition. The trial is taking place at multiple locations, and they are currently looking for participants aged 18 to 75 who have been diagnosed with this kidney disease through a biopsy and have a specific level of protein in their urine.

To participate, individuals must have a positive test for a specific antibody related to this condition and should not have other serious kidney issues or uncontrolled health conditions like high blood pressure or diabetes. Participants will be monitored throughout the study to see how well the treatment works and if there are any side effects. It's important for anyone interested to understand that they will need to sign a consent form before joining and that they should not be involved in other clinical trials at the same time.

Gender

ALL

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.