Primary Membranous NephropathyPhase 3NCT06781944
OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)
A Phase 3 study testing Obinutuzumab and CTX combined with Glucocorticoids in people with Primary Membranous Nephropathy, run by Huashan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Obinutuzumab and CTX combined with Glucocorticoids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 31 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Qionghong Xie Q Qionghong Xie, 18121186869, qionghongxie@fudan.edu.cn
About this study
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)
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
- Being tested
- Obinutuzumab, CTX combined with Glucocorticoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Drug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.
CTX combined with GlucocorticoidsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab | Experimental | Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26. Receives: Drug: Obinutuzumab |
| Comparator | Other | Comparator Receives: Drug: CTX combined with Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: 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
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.
Measured: 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
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
Measured: Month 12
The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at 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).
Measured: Month 12
The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at 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.
Measured: 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
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.
Measured: Month 18
The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at 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).
Measured: Month 18
The proportion of patients who achieve PR assessed by 24-hour urinary protein to creatinine ratio at 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.
Measured: Month 18
The proportion of patients who achieve CR assessed by 24-hour urinary protein to creatinine ratio at 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).
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start23 Oct 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanming Hao, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781944
- Sponsor's protocol ID
- ML45515
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In signing the final protocol, every participating Investigator agrees to keep all information and results concerning the study and the investigational product confidential for as long as the data remain unpublished. The confidentiality obligation applies to all personnel involved at the investigational site. In the conduct of this trial 10 centers will be involved. The size of the author list will be dictated by the journal(s) to which the abstract is submitted, but will include Professor Chuan-Ming Hao, the Primary Investigator for the study, as first or corresponding author. Other named authors will be included up to the maximum number allowed by the journal and will be selected based on recruitment at individual sites. If data is to be presented outside the individual institutions involved in the study, the Sponsor and Steering Committee should approve the content.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06781944
- Acronym / sponsor ID
- ML45515
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab | Experimental | Drug: ObinutuzumabIntravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26. |
| Comparator | Other | Drug: CTX combined with GlucocorticoidsComparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObinutuzumabDrug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26. | Drug | Obinutuzumab |
| CTX combined with GlucocorticoidsDrug: 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. | Drug | Comparator |
Primary outcome
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]).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided. In signing the final protocol, every participating Investigator agrees to keep all information and results concerning the study and the investigational product confidential for as long as the data remain unpublished. The confidentiality obligation applies to all personnel involved at the investigational site. In the conduct of this trial 10 centers will be involved. The size of the author list will be dictated by the journal(s) to which the abstract is submitted, but will include Professor Chuan-Ming Hao, the Primary Investigator for the study, as first or corresponding author. Other named authors will be included up to the maximum number allowed by the journal and will be selected based on recruitment at individual sites. If data is to be presented outside the individual institutions involved in the study, the Sponsor and Steering Committee should approve the content.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Obinutuzumab and CTX combined with Glucocorticoids in people with Primary Membranous Nephropathy, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuanming Hao C Chuanming Hao (+86-13501639098, chuanminghao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.