Comparing Mescaline Sodium Enteric-coated Tablets vs Morte-mescaline in the Treatment of Adult Lupus Nephritis

Phase 4

Not yet recruiting

• Conditions: Lupus Nephritis
• Interventions: Drug: Mescaline sodium enteric-coated tablets; Drug: Morte-mescaline; Drug: Glucocorticoids

• Registration Number: NCT05933213
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Study Start: 2023-07-06
• Study First Posted: 2023-07-06
• Last Update Posted: 2023-07-06
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 205

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mescaline sodium enteric-coated tablets group	Mescaline sodium enteric-coated tablets	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
Mescaline sodium enteric-coated tablets group	Glucocorticoids	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	Glucocorticoids	Treating with glucocorticoids + morte-mescaline 1. Induction period: Prednisone tablets: oral, recommended dose 0.4-0.8 mg/kg/d, with gradual dose reduction (10% per month) at the end of 3-6 months; mortifamate: oral, twice a day, dose 1-2 g/d, 3-6 months; 2. Maintenance period: Prednisone tablets 5-7.5 mg/d, mortifamate 0.5-0.75 g/d, with maintenance treatment for 1 year.
Morte-mescaline group	Morte-mescaline	Treating with glucocorticoids + morte-mescaline 1. Induction period: Prednisone tablets: oral, recommended dose 0.4-0.8 mg/kg/d, with gradual dose reduction (10% per month) at the end of 3-6 months; mortifamate: oral, twice a day, dose 1-2 g/d, 3-6 months; 2. Maintenance period: Prednisone tablets 5-7.5 mg/d, mortifamate 0.5-0.75 g/d, with maintenance treatment for 1 year.

Primary Outcome Measures

Name	Time	Method
Total effective rate	180 days of treatment	(Complete remission + Partial remission) / total number of cases

Secondary Outcome Measures

Name	Time	Method
Overall incidence of adverse events and serious adverse reactions	540 days of treatment	Safety evaluation