Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus, Lupus Nephritis
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring mycophenolate mofetil, tacrolimus, steroid tapering, systemic lupus erythematosus, lupus nephritis
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
steroid tapering group
steroid maintenance group
0~6th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) + steroid (1 pill/d) 6th~18th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) 18th~30th month: Participants who stop steroid treatment and do not flare will be randomly assigned to monotherapy with mycophenolate mofetil or tacrolimus
0~18th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) + steroid (1 pill/d) 18th~30th month: Participants who do not flare will be randomly assigned to therapy with mycophenolate mofetil + steroid (1 pill/d) or tacrolimus + steroid (1 pill/d)