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Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus
NCT05916781 · Chinese SLE Treatment And Research Group
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus: A Prospective, Random Control, Open-label, Single Center Clinical Trial
About this study
According to the references, with the maintenance of steroid, 1-year lupus flare rate is 7%. Investigators plan to take a 2-year follow-up for participants, so the proportion of patients without flare in steroid maintenance group should be 86%. As this is a non-inferiority study, investigators hypothesize that in steroid tapering group, the proportion of patients without flare is also 86%. Investigators set α=0.05 (two-sided), 1-β=0.90, non-inferiority value = 15%, the dropout rate = 20%. The sample size of each group should be 110, the 220 in total.
Eligibility criteria
Inclusion Criteria:
* Systemic lupus erythematosus participants diagnosed with 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria, fulfilled with American College of Rheumatology (ACR) lupus nephritis definition, and have reached treatment target (accord with lupus nephritis clinical remission and DORIS) for at least 6 months. The target is defined as: (1)24h urine protein ≤0.5g/d;(2)stable of improved renal function (baseline creatinine ±10% or decrease 15%);(3)clinical SLE Disease Activity Index (cSLEDAI) =0 (all scores are required zero, except hypocomplementemia and anti-dsDNA antibody positivity);(4)PGA score (Physician Global Assessment)\<0.5; (5)prednisone or equivalent steroid dose≤5mg/d;(6)stable use of immunosuppressants and antimalarial drugs; (7)no use of biological agents.
* According to the physician, the participant can accept this treatment.
* The participant is willing to join this clinical trial, has good compliance, and could understand and sign the informed consent before the study begins.
Exclusion Criteria:
* SLE complicated with important organ dysfunction, including consciousness disorder, cognitive disorder, renal dysfunction, heart dysfunction (NYHA class 3, 4), pulmonary arterial hypertension, and interstitial lung disease.
* SLE with active vital organ disease (not satisfied with DORIS), including but not limited to active neuropsychiatric systemic lupus erythematosus, lupus nephritis, thrombocytopenia, hemolytic anemia, myocardial involvement, gastrointestinal involvement, etc.
* Participants who are allergic to or intolerant with mycophenolate mofetil or tacrolimus.
* Participants with acute and chronic infections requiring anti-infective treatment, including but not limited to tuberculosis infection, Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection, Human Immunodeficiency Virus (HIV) infection, and Cytomegalovirus (CMV) infection.
* Participants who are pregnant or planning to become pregnant.
* Participants who have used biological agents within 6 months before enrollment.
* The researcher considers any condition that may cause the participant to be unable to complete the study or bring an obvious risk to the participant.
Study design
Enrollment target: 220 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-07-01
Estimated completion: 2026-07-31
Last updated: 2024-07-09
Interventions
Drug: Mycophenolate MofetilDrug: TacrolimusDrug: Glucocorticoid
Primary outcomes
- • The 1-year flare rate of lupus nephritis participants who reach the treatment target and accept MMF+TAC remedy tapering steroid in the maintenance period. (6th~18th month)
Sponsor
Chinese SLE Treatment And Research Group · other
With: Peking Union Medical College Hospital
Contacts & investigators
ContactCan Huang, MD · contact · huang_can@yeah.net · 86-13426191948
InvestigatorMengtao Li, MD · study_chair, Peking Union Medical College Hospital
All locations (1)
Peking Union Medical College HospitalRecruiting
Beijing, China