Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus

Launched by CHINESE SLE TREATMENT AND RESEARCH GROUP · Jun 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of two medications, mycophenolate mofetil (MMF) and tacrolimus (TAC), can help patients with lupus nephritis maintain their health after reducing their use of steroids. Lupus nephritis is a serious condition that affects the kidneys in people with systemic lupus erythematosus (SLE). The trial will compare two groups: one group will stop taking steroids while continuing MMF and TAC for a year, while the other group will keep taking a low dose of steroids along with MMF and TAC for the same period. The researchers aim to find out if this combination treatment is safe and effective, as well as how it affects other health factors.

To participate in this trial, individuals must have a diagnosis of systemic lupus erythematosus and meet specific health criteria, such as having stable kidney function and no active disease for at least six months. Participants should be between 18 and 74 years old and must be willing to follow the study guidelines. Those who join can expect regular check-ups and monitoring to ensure their safety and to track the effectiveness of the treatment. It's important to know that the trial is currently recruiting participants and aims to help improve treatment options for lupus nephritis.

Gender

ALL

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.