Actively Recruiting
OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)
Led by Huashan Hospital · Updated on 2026-01-21
144
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at the time of signing informed consent
- Diagnosed with primary membranous nephropathy by kidney biopsy within 5 years or serum anti-PLA2R antibody level of at least 14 RU/ml
- 24-hour urine protein to creatinine ratio of 4 g/g or more and serum albumin below 30 g/L despite treatment with ACE inhibitors and/or ARBs for at least 6 months, or 24-hour urine protein to creatinine ratio of 5 g/g or more and serum albumin below 30 g/L despite treatment with ACE inhibitors and/or ARBs for at least 3 months, or 24-hour urine protein to creatinine ratio of 8 g/g or more and serum albumin below 25 g/L despite treatment with ACE inhibitors and/or ARBs for at least 1 month
- Estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73m2 or higher (CKD-EPI); if eGFR is below 60 mL/min/1.73m2, a kidney biopsy is needed to rule out other kidney damage
- Ability to follow the study protocol as judged by the investigator
You will not qualify if you...
- Secondary causes of membranous nephropathy such as hepatitis B, systemic lupus erythematosus, medication-related causes, or cancers
- Type 1 or type 2 diabetes mellitus
- Estimated glomerular filtration rate (eGFR) below 40 mL/min/1.73m2, dialysis, or previous kidney transplantation
- Evidence of a 50% reduction in proteinuria or serum anti-PLA2R antibody levels within 6 months before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
C
Chuanming Hao C Chuanming Hao
CONTACT
Q
Qionghong Xie Q Qionghong Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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