Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06781944

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Primary Membranous Nephropathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Qionghong Xie Q Qionghong Xie

CONTACT

[email protected]

18121186869

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obinutuzumab

Drug

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

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.

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

    Time frame: 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]).

Secondary 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 6

    Time frame: Month 6

    Collect 24-hour urine from patients in the 6th 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]).

    • CR is defined as a urinary protein-to-creatinine ratio (UPCR) ≤0.3 g/g (24-hour urine).
    • PR is defined as reduction of urinary protein-to-creatinine ratio (UPCR) (24-hour urine) from baseline ≥ 50% ,plus ≤3.5 g/g but >0.3 g/g.

  2. 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

    Collect 24-hour urine from patients in the 12th month and perform 24-hour urinary protein to creatinine ratio (24-hour UPCR) testing to evaluate the proportion of patients who achieve OR(Complete remission [CR] or prtial remission[PR]) .

    • CR is defined as a urinary protein-to-creatinine ratio (UPCR) ≤0.3 g/g (24-hour urine)
    • PR is defined as reduction of urinary protein-to-creatinine ratio (UPCR) (24-hour urine) from baseline ≥ 50% ,plus ≤3.5 g/g but >0.3 g/g

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

    Time frame: Month 12

    Collect 24-hour urine from patients in the 12th month and measure the 24-hour urinary protein to creatinine ratio (24-hour UPCR) to evaluate the proportion of patients achieving CR.

    · CR is defined as a urinary protein-to-creatinine ratio (UPCR) ≤0.3 g/g (24-hour urine).

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

    Time frame: Month 12

    Collect 24-hour urine from patients in the 12th month and measure the 24-hour urinary protein to creatinine ratio (24-hour UPCR) to evaluate the proportion of patients achieving PR.

    • PR is defined as reduction of urinary protein-to-creatinine ratio (UPCR) (24-hour urine) from baseline ≥ 50% ,plus ≤3.5 g/g but >0.3 g/g.

  5. 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

    Collect 24-hour urine from patients in the 18th month and perform 24-hour urinary protein to creatinine ratio (24-hour UPCR) testing to evaluate the proportion of patients who achieve OR(Complete remission [CR] or artial remission[PR]) .

    • CR is defined as a urinary protein-to-creatinine ratio (UPCR) ≤0.3 g/g (24-hour urine).
    • PR is defined as reduction of urinary protein-to-creatinine ratio (UPCR) (24-hour urine) from baseline ≥ 50% ,plus ≤3.5 g/g but >0.3 g/g.

  6. The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at Month 18

    Time frame: Month 18

    Collect 24-hour urine from patients in the 12th month and measure the 24-hour urinary protein to creatinine ratio (24-hour UPCR) to evaluate the proportion of patients achieving CR.

    · CR is defined as a urinary protein-to-creatinine ratio (UPCR) ≤0.3 g/g (24-hour urine).

  7. The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at Month 18

    Time frame: Month 18

    Collect 24-hour urine from patients in the 18th month and measure the 24-hour urinary protein to creatinine ratio (24-hour UPCR) to evaluate the proportion of patients achieving PR.

    · PR is defined as reduction of urinary protein-to-creatinine ratio (UPCR) (24-hour urine) from baseline ≥ 50% ,plus ≤3.5 g/g but >0.3 g/g.

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

    Time frame: Month 24

    Collect 24-hour urine from patients in the 12th month and measure the 24-hour urinary protein to creatinine ratio (24-hour UPCR) to evaluate the proportion of patients achieving CR.

    • CR is defined as a urinary protein-to-creatinine ratio (UPCR) ≤0.3 g/g (24-hour urine).

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanming Hao C Chuanming Hao

CONTACT

[email protected]

+86-13501639098

Qionghong Xie Q Qionghong Xie

CONTACT

[email protected]

+86-18121186869

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.