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| Name | Class |
|---|---|
| Beijing Medical Award Foundation | UNKNOWN |
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The goal of this prospective, multicenter,real-world study is to To evaluate the efficacy and safety of mescaline sodium enteric-coated tablets versus morte-mescaline in the treatment of adult patients with lupus nephritis under real-life medical conditions.
The main question it aims to answer are: Is the efficacy of mescaline sodium enteric-coated tablets in the treatment of adult patients with lupus nephritis not inferior to morti-mescaline? Participants will receive induction and maintenance treatment with mescaline sodium enteric-coated tablets and morte-mescaline.Then participants will be followed up at 60, 180, 270 and 540 days of treatment to assess the efficacy and safety of mescaline sodium enteric-coated tablets compared to morte-mescaline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mescaline sodium enteric-coated tablets group | Experimental | Treating with glucocorticoids + mescaline sodium enteric-coated tablets (1) Induction period: Prednisone tablets: orally, recommended dose 0.4-0.8 mg/kg/d, with gradual dose reduction (10% per month) at the end of 3-6 months; mescaline sodium enteric-coated tablets: orally, twice a day, at 720-1440 mg/d, for 3-6 months; (2) Maintenance period: Prednisone tablets 5-7.5 mg/d, mescaline sodium enteric-coated tablets 360-540mg/d, maintenance treatment for 1 year |
|
| Morte-mescaline group | Active Comparator | Treating with glucocorticoids + morte-mescaline
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mescaline sodium enteric-coated tablets | Drug | Induction period: orally, twice a day, at 720-1440 mg/dï¼› Maintenance period: orally, twice a day, 360-540mg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total effective rate | (Complete remission + Partial remission) / total number of cases | 180 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of adverse events and serious adverse reactions | Safety evaluation | 540 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LUO HUI, Doctor | Contact | +86-13974871326 | luohuihn@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| LUO HUI, Doctor | Xiangya Hospital of Central South University | Principal Investigator |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| 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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| Morte-mescaline | Drug | Induction period: orally, twice a day, 1-2 g/d; Maintenance period: orally, twice a day, 0.5-0.75 g/d |
|
| Glucocorticoids | Drug | glucocorticoids |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |