Comparing obinutuzumab to cyclophosphamide and glucocorticoids for treating primary membranous nephropathy

A Multicenter, Open- Label, Randomized, Clinical Trial to Investigate the Efficacy and Safety of OBINOTUZUMAB Versus Cyclophosphamide Combined With Glucocorticoids in Patients With Primary Membranous Nephropathy (Blossom Study)

This study is testing if a new drug called obinutuzumab works just as well as the standard treatment of cyclophosphamide and glucocorticoids for people with primary membranous nephropathy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Drugs / interventions: obinutuzumab, cyclophosphamide, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06781944 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of primary membranous nephropathy and specific proteinuria and serum albumin levels despite prior treatment.

Not a fit: Patients with secondary causes of membranous nephropathy or those with significant renal damage due to other comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with primary membranous nephropathy that may be more effective or have fewer side effects than current therapies.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in using monoclonal antibodies for autoimmune conditions, suggesting potential for success.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chuanming Hao C Chuanming Hao

Conditions Primary Membranous Nephropathy