Lupus Nephritis
Conditions
Keywords
Lupus Nephritis, mescaline sodium enteric-coated tablets, morte-mescaline
Brief summary
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.
Interventions
DRUGMescaline sodium enteric-coated tablets
Induction period: orally, twice a day, at 720-1440 mg/d； Maintenance period: orally, twice a day, 360-540mg/d
DRUGMorte-mescaline
Induction period: orally, twice a day, 1-2 g/d; Maintenance period: orally, twice a day, 0.5-0.75 g/d
DRUGGlucocorticoids
glucocorticoids
Sponsors
Beijing Medical Award Foundation
Xiangya Hospital of Central South University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age 18-70 years; 2. Meet the 2019 SLE classification criteria established by EULAR/ACR; 3. Have any of the following clinical and laboratory abnormalities: 1) proteinuria \>0.5 g/24h, or urine protein ++++ on random urinalysis, or urine protein/creatinine ratio EE \>500 mg/g (50 mg/mmol); 2) cellular tubularity including erythrocyte tubularity, hemoglobin tubularity, granular tubularity, tubular tubularity, or mixed tubularity; 3) active urinary sediment (except 3) active urine sediment (except urinary tract infection, urine leukocytes \>5/HPF, urine red blood cells \>5/HPF), or erythrocyte tubular, or leukocyte tubular; 4. 24h urine protein quantification ≥ 1.0 g; 5. Require long-term treatment with MPA-type drugs (mescaline sodium enteric-coated tablets or morte-mescaline); 6. Singed the informed consent.
Exclusion criteria
* 1\. Patients treated with immunosuppressive agents (e.g. CTX, MPA, CNI, etc.) within 30 days 2. Patients with co-morbid severe CNS infections 3. Neutrophil counts \<1×103/µl; 4. Glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 ; 5. Glutamic aminotransferase (ALT), glutamic oxalacetic aminotransferase (AST) or total bilirubin \> 1.5 x upper limit of normal (ULN); 6. Pregnant or lactating women 7. Presence of other major diseases such as tumors, HIV viral infections, systemic bacterial/fungal/viral infections; 8. Presence of contraindications to glucocorticoids and investigational drugs 9. Any condition that, in the judgment of the investigator, is unstable or may jeopardize the safety of the subject and his or her compliance with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total effective rate | 180 days of treatment | (Complete remission + Partial remission) / total number of cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall incidence of adverse events and serious adverse reactions | 540 days of treatment | Safety evaluation |
Contacts
Primary ContactLUO HUI, Doctor
Outcome results
None listed