OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)

NCT06781944 | Recruiting Phase 3

• 1 other identifier: ML45515
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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

  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 \[PR\]).

  Month 24

Secondary Outcomes (8)

• 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 6

  Month 6

• 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 12

  Month 12

• The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 12

  Month 12

• The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at Month 12

  Month 12

• The proportion of patients who achieve overall remission (OR) (Complete remission [CR] or artial remission[PR]) assessed by 24-hour urinary protein to creatinine ratio at Month 18

  Month 18

Study Arms (2)

Obinutuzumab

EXPERIMENTAL

Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.

Drug: Obinutuzumab

Comparator

OTHER

Comparator

Drug: CTX combined with Glucocorticoids

Interventions

Obinutuzumab DRUG

Drug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.

Obinutuzumab

CTX combined with Glucocorticoids DRUG

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.

Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Interventions

obinutuzumab; Glucocorticoids

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Chuanming Hao C Chuanming Hao

CONTACT

+86-13501639098; chuanminghao@fudan.edu.cn

Qionghong Xie Q Qionghong Xie

CONTACT

+86-18121186869; qionghongxie@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 17, 2025
• Study Start: October 23, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: January 21, 2026

Record last verified: 2025-12

Locations

CN (1)