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This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.
The study consists of four stages as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio. Medication regimen of Group A: Prednisone:the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation; Cyclophosphamide injection:an intravenous injection of 0.4 g is administered twice a month. |
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| Group B | Experimental | Medication regimen of Group B: Prednisone:the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation; Telitacicept injection:an intravenous injection of 0.4 g is administered twice a month. |
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| Group C | Active Comparator | After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Non-responders are randomly assigned to either Group C or Group D at a 1:1 ratio. Medication regimen of Group C: Prednisone:the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation; Cyclophosphamide injection:an intravenous injection of 0.4 g is administered twice a month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Drug | Subcutaneous injection of 160 mg is administered once a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate at the end of follow-up (21 months post-treatment) | Complete remission defined as 24h urine protein quantification ≤0.3g/24h. | 21 months |
| Partial remission rate at the end of follow-up (21 months post-treatment) | Partial remission defined as 24h proteinuria quantification <3.5g/24h or ≥50% reduction from baseline and stable serum creatinine or <30% increase from baseline value. | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of relapse of nephrotic syndrome at months 3, 6, 9, 12, 15, 18, and 21 after treatment | Recurrence of proteinuria >3.5 g/24h or at least a ≥50% increase from the nadir was defined as recurrence of nephrotic syndrome in patients who had achieved partial or complete remission. | 3-21 months |
| Incidence of adverse events in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiming Wang, PhD | Contact | +86 18971563100 | rm000301@whu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan university | Wuhan | Hubei China | 430075 | China |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
| D011241 | Prednisone |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio. Non-responders are also randomly assigned to either Group C or Group D at a 1:1 ratio. Treatment administration is subsequently carried out based on group assignment.
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| Group D | Experimental | Medication regimen of Group D: Prednisone:the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation; Telitacicept injection:an intravenous injection of 0.4 g is administered twice a month. |
|
| Prednisone | Drug | Induction therapy period (3 months):Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks) Grouped treatment period (6 months): The maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation. |
|
| Cyclophosphamide | Drug | An intravenous injection of 0.4 g is administered twice a month. |
|
This trial specifies that the recording of adverse events shall be recorded as a medical history from the time the subject receives the induction phase treatment administration, and from the time of signing the informed consent form until the clinical diagnosis, abnormal signs and symptoms, and examination findings occurring prior to the administration of the induction phase treatment. |
| 0-21 months |
| Complete remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment | Complete remission defined as 24h urine protein quantification ≤0.3g/24h. | 3-21 months |
| Partial remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment | Partial remission defined as 24h proteinuria quantification <3.5g/24h or ≥50% reduction from baseline and stable serum creatinine or <30% increase from baseline value. | 3-21 months |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |