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This random, open, control and multicenter clinical trial mainly aims to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus monotherapy | Experimental |
| |
| Tacrolimus combined with hormone therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | The initial dose of TAC is 0.05-0.1 mg/kg/d, taking 2 hours before and after meals. The interval is strictly 12 hours. The blood concentration is measured after taking the drug. According to the concentration of blood drug valley, the dose of tacrolimus (blood concentration of ≤10ng/ml) is adjusted. If the blood drug concentration is low, the drug dose (≤0.1mg/kg/d) is increased accordingly. After 6 months of treatment, the drug is discontinued. The TAC dose is maintained at the original dose after 6 months of treatment with complete or partial remission of urinary protein until the end of the 48-week trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate of 24-hour urine protein | The proportion of patients with complete remission of 24-hour urine protein in the total evaluated patients. Evaluation criteria of complete remission: post-therapy urine protein level is <0.3g/24h. | At week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Partial remission remission rate of 24-hour urine protein | The proportion of patients with partial remission of 24-hour urine protein in the total evaluated patients. Evaluation criteria of partial remission: post-therapy urine protein decline is >50% compared with the peak value. | At week 48 |
| PLA2R antibody negative conversion rate |
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Inclusion Criteria:
Age: 18 - 80 years;
Those whose clinical manifestation and renal biopsy pathologic diagnosis are IMN (Stages I-IV) with secondary membranous nephropathy excluded;
Those who meet any of the following high-risk IMN standards:
Those without reaching the above high-risk IMN standard, but their course of disease is >6 months without spontaneous remission,and still present nephrotic syndrome;
Patients who have signed the informed consent forms.
Exclusion Criteria:
Exit criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fujun Lin, MD,PhD | Contact | +86-13917983703 | linfujun@xinhuamed.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xinhua Hospital affliated to Shanghai Jiao Tong University, School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011244 | Pregnadienediols |
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|
| Prednisone | Drug | The initial dose of prednisone is 0.5 mg/kg/d orally (maximum dose 40 mg/d), and after 8-12 weeks, the dose was gradually reduced until discontinuation. TAC treatment is given at the same time (the treatment plan is the same as the experimental group). |
|
The proportion of patients with PLA2R antibody negative conversion in the total evaluated patients. Evaluation criteria of negative conversion: PLA2R antibody level is <20RU/ml. |
| At week 48 |
| Number of patients with adverse events | Number of patients with adverse events | Up to 48 weeks |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |