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Recruiting NCT06781944

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

Phase III Interventional Primary Membranous Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Obinutuzumab, CTX combined with Glucocorticoids.
Who it may be relevant to
Registry conditions: Primary Membranous Nephropathy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

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

Primary outcome measures

  • 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 [Time frame: Month 24]
Secondary outcome measures (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 [Time frame: 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 [Time frame: Month 12]
  • The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 12 [Time frame: Month 12]
  • The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at Month 12 [Time frame: 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 [Time frame: Month 18]
  • The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 18 [Time frame: Month 18]
  • The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at Month 18 [Time frame: Month 18]
  • The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 24 [Time frame: Month 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06781944 · ML45515

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗