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

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ClinicalTrials.gov Identifier: NCT05933213
Recruitment Status : Not yet recruiting
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Collaborator:
Beijing Medical Award Foundation
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Mescaline sodium enteric-coated tablets Drug: Morte-mescaline Drug: Glucocorticoids Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 205 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 6, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Peyote

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mescaline sodium enteric-coated tablets group

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

Drug: Glucocorticoids
glucocorticoids
Active Comparator: Morte-mescaline group

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
Induction period: orally, twice a day, 1-2 g/d; Maintenance period: orally, twice a day, 0.5-0.75 g/d

Drug: Glucocorticoids
glucocorticoids


Outcome Measures
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Primary Outcome Measures :
  1. Total effective rate [ Time Frame: 180 days of treatment ]
    (Complete remission + Partial remission) / total number of cases


Secondary Outcome Measures :
  1. Overall incidence of adverse events and serious adverse reactions [ Time Frame: 540 days of treatment ]
    Safety evaluation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933213


Contacts
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Contact: LUO HUI, Doctor +86-13974871326 luohuihn@sina.com

Sponsors and Collaborators
Xiangya Hospital of Central South University
Beijing Medical Award Foundation
Investigators
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Principal Investigator: LUO HUI, Doctor Xiangya Hospital of Central South University
More Information
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT05933213    
Other Study ID Numbers: YXJL-2023-0532-0027
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
Lupus Nephritis
mescaline sodium enteric-coated tablets
morte-mescaline
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Mescaline
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action