OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)
NCT ID: NCT06781944
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
144 participants
INTERVENTIONAL
2024-10-23
2028-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
NONE
Study Groups
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Obinutuzumab
Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.
Obinutuzumab
Drug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.
Comparator
Comparator
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Chuanming Hao
Professor
Locations
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Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ML45515
Identifier Type: -
Identifier Source: org_study_id
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