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

Lupus Nephritis Clinical Trial

Official title:

Comparing Efficacy and Safety of Mescaline Sodium Enteric-coated Tablets vs Morte-mescaline in the Treatment of Adult Lupus Nephritis: A Prospective, Multicenter,Real-world Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933213
• Other study ID #: YXJL-2023-0532-0027
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 6, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Xiangya Hospital of Central South University
• Contact: LUO HUI, Doctor
• Phone: +86-13974871326
• Email: luohuihn[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 205
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Mescaline sodium enteric-coated tablets
Induction period: orally, twice a day, at 720-1440 mg/d; Maintenance period: orally, twice a day, 360-540mg/d
• Morte-mescaline
Induction period: orally, twice a day, 1-2 g/d; Maintenance period: orally, twice a day, 0.5-0.75 g/d
• Glucocorticoids
glucocorticoids

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	Beijing Medical Award Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total effective rate	(Complete remission + Partial remission) / total number of cases	180 days of treatment
Secondary	Overall incidence of adverse events and serious adverse reactions	Safety evaluation	540 days of treatment