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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab | Experimental | Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26. |
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| Comparator | Other | Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Drug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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]). | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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]).
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanming Hao C Chuanming Hao | Contact | +86-13501639098 | chuanminghao@fudan.edu.cn | |
| Qionghong Xie Q Qionghong Xie | Contact | +86-18121186869 | qionghongxie@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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Intervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26,Comparator: Cyclical cyclophosphamide and glucocorticoids
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| 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. |
|
| 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]) .
| 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). | 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.
| 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]) .
| 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). | 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. | 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.
| Month 24 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |