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

NCT05933213 | Unknown Phase 4

• 1 other identifier: YXJL-2023-0532-0027
• Study Type: interventional
• Target: 205
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis; mescaline sodium enteric-coated tablets; morte-mescaline

Outcome Measures

Primary Outcomes (1)

• Total effective rate

  (Complete remission + Partial remission) / total number of cases

  180 days of treatment

Secondary Outcomes (1)

• Overall incidence of adverse events and serious adverse reactions

  540 days of treatment

Study Arms (2)

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

Drug: Mescaline sodium enteric-coated tablets; Drug: Glucocorticoids

Morte-mescaline group

ACTIVE COMPARATOR

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.

Drug: Morte-mescaline; Drug: Glucocorticoids

Interventions

Mescaline sodium enteric-coated tablets DRUG

Induction period: orally, twice a day, at 720-1440 mg/d； Maintenance period: orally, twice a day, 360-540mg/d

Mescaline sodium enteric-coated tablets group

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

Morte-mescaline group

Glucocorticoids DRUG

glucocorticoids

Mescaline sodium enteric-coated tablets group; Morte-mescaline group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Beijing Medical Award Foundation: collaborator

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• LUO HUI, Doctor

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUO HUI, Doctor

CONTACT

+86-13974871326; luohuihn@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: July 6, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 6, 2023

Record last verified: 2023-06