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
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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 |
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Lupus Nephritis | Drug: Mescaline sodium enteric-coated tablets Drug: Morte-mescaline Drug: Glucocorticoids | Phase 4 |
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 |
Arm | Intervention/treatment |
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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
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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 |
- Total effective rate [ Time Frame: 180 days of treatment ](Complete remission + Partial remission) / total number of cases
- Overall incidence of adverse events and serious adverse reactions [ Time Frame: 540 days of treatment ]Safety evaluation
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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 |
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.
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
Contact: LUO HUI, Doctor | +86-13974871326 | luohuihn@sina.com |
Principal Investigator: | LUO HUI, Doctor | Xiangya Hospital of Central South University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lupus Nephritis mescaline sodium enteric-coated tablets morte-mescaline |
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 |