Comparing obinutuzumab to cyclophosphamide and glucocorticoids for treating primary 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 Phase III clinical trial evaluates the efficacy and safety of obinutuzumab compared to a combination of cyclophosphamide and glucocorticoids in patients diagnosed with primary membranous nephropathy (pMN). Approximately 144 participants will be enrolled, with treatment involving intravenous infusions of obinutuzumab or a regimen of cyclophosphamide and glucocorticoids. The study aims to determine if obinutuzumab is non-inferior to the standard treatment in managing pMN symptoms and improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18～75 years (including 18 and 75)old at the time of signing Informed Consent Form
* pMN patients diagnosed according to renal biopsy (original biopsy needs to include light, immunofluorescence, and electron microscopy) within 5 years or serum anti-PLA2R antibody (≥14 RU/ml )
* 24-hour UPCR ≥ 4 g/g and serum albumin (sALB) \< 30 g/L,despite being treated with ACEi and/or ARB for ≥ 6 months prior to screening, or 24-hour UPCR ≥ 5 g/g and sALB \< 30 g/L , despite being treated with ACEi and/or ARB for ≥ 3 months prior to screening; or 24-hour UPCR ≥ 8 g/g and sALB \< 25 g/L, despite being treated with ACEi and/or ARB for ≥ 1 month prior to screening,.
* eGFR ≥40 mL/min/1.73m2 (CKD-EPI), a renal biopsy is required to exclude renal damage due to other co-morbidities if eGFR \<60mL/min/1.73 m2.
* Ability to comply with the study protocol, in the investigator's judgment

Exclusion Criteria:

* Patients with a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus, medications, malignancies)
* Type 1 or 2 diabetes mellitus
* eGFR \<40 mL/min/1.73m2 (CKD-EPI) or dialysis or kidney transplantation
* Evidence of 50% reduction in proteinuria or serum anti-PLA2R antibody within 6 months prior to screening

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chuanming Hao C Chuanming Hao
• Email: chuanminghao@fudan.edu.cn
• Phone: +86-13501639098

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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.