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

This open-label, phase IV interventional trial (n=205) aims to compare the efficacy and safety of mescaline sodium enteric-coated tablets with morte-mescaline in treating adult lupus nephritis (lupus autoantibodies affect parts of the kidneys that filter out waste) under real-world medical conditions.

Led by Xiangya Hospital of Central South University, the study evaluates whether the efficacy of mescaline sodium enteric-coated tablets is non-inferior to morte-mescaline. Participants meeting specific criteria, aged 18-70, and diagnosed with lupus nephritis, will receive induction and maintenance treatment with either mescaline sodium enteric-coated tablets or morte-mescaline.

The primary outcome measure is the total effective rate assessed at 180 days, while the secondary outcome includes the overall incidence of adverse events and serious adverse reactions evaluated over 540 days. The study commenced on July 6, 2023, with an estimated completion date of December 2025.

Note: This research has been covered briefly in a review, but the dosing and broken first English sentence make us wonder if there is not a coding/translation error somewhere (i.e. dosing every day with mescaline doesn’t seem right, nor does the comparison between different chemical versions seem what we need to do right now).

Trial Details

The goal of this prospective, multicenter, real-world study is 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.

NCT Number NCT05933213

Data attribution

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