Obinutuzumab: Drug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.
CTX combined with Glucocorticoids: Drug: Glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg/kg/d (max 40mg/d) for 27 days.
Drug: CTX
Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.
Study summary
This is a randomized, parallel group, active-controlled, open-label, Phase III study comparing the efficacy and safety of obinutuzumab versus cyclophosphamide combined with glucocorticoids in patients with primary membranous nephropathy (pMN). Approximately 144 patients with pMN who have been diagnosed by biopsy or serum anti-PLA2R antibody will be enrolled.
Intervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26 Comparator: Cyclical cyclophosphamide and glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg/kg/d (max 40 mg/d) for 27 days.
Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
The proportion of patients who achieve overall remission (OR) (Complete remission [CR] or prtial remission[PR]) assessed by 24-hour urinary protein to creatinine ratio at Month 24 — Month 24 Collect 24-hour urine from patients in the 24th month and measure the 24-hour urinary protein to creatinine ratio (24-hour UPCR) to evaluate the proportion of patients achieving total response (OR) (complete response \[CR\] or partial response \[PR\]).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.