Huaier granule treatment for idiopathic membranous nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: shengdai26@163.com
• Phone: 00-86-010-66937166

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dermal priming to boost flu vaccine response in people on B cell depletion

  This study tests whether applying a topical cream with imiquimod on the skin around vaccination can boost the body’s response to the flu shot in people who are receiving B cell–depleting therapy.

  Recruiting Cambridge University Hospitals NHS Foundation Trust · Cambridge · NCT07925996

• Rivaroxaban to prevent blood clots in idiopathic membranous nephropathy

  This trial will test whether daily rivaroxaban prevents dangerous blood clots better than warfarin in adults with idiopathic membranous nephropathy who have nephrotic syndrome and very low albumin.

  Recruiting Phase 4 Beijing Friendship Hospital · Beijing, Beijing Municipality · NCT07404436

• BK virus in kidney transplant patients and donors: who carries the virus and why

  This study tests BK virus in kidney transplant recipients and their donors to see where the virus comes from and how the immune system responds.

  Recruiting University Hospital, Grenoble · Grenoble · NCT07347769

• Diabetes Complications in People with Cystic Fibrosis-Related Diabetes (SPeCTRuM)

  This project will see how common diabetes-related complications (like eye, nerve, and blood vessel problems) are in adolescents and adults living with cystic fibrosis-related diabetes.

  Recruiting at 5 sites Jaeb Center for Health Research · Birmingham, Alabama and 17 other locations · NCT06837181

• Using anti-CD19 CAR NK cells to treat immune nephropathy

  This study is testing if a new type of cell therapy can help people with tough-to-treat immune nephropathy feel better and improve their kidney function.

  Recruiting Early Phase 1 Changhai Hospital · Shanghai · NCT06469190

• Investigating kidney cell regeneration in nephropathy

  This study is testing how certain kidney cells can help repair damage in people with kidney disease and acute kidney injury.

  Recruiting Meyer Children's Hospital IRCCS · Florence · NCT06325059

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.