Actively Recruiting
Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus
Led by Chinese SLE Treatment And Research Group · Updated on 2024-07-09
220
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
C
Chinese SLE Treatment And Research Group
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine whether mycophenolate mofetil(MMF) combined with tacrolimus(TAC) can maintain remission in patients with lupus nephritis (LN) who have reached treatment targets after steroid tapering. The main question\[s\] it aims to answer are: * The efficacy, safety and tolerability of MMF combined with TAC regimen in the treatment of LN patients in the maintenance period. * The influence of low-dose steroid on carotid intima thickness (CIMT). * The omics and cell-free RNA (cfRNA) spectral differences related to lupus flare. * The differences in health economics between steroid tapering and steroid maintenance patients. Participants will be randomly assigned into 2 groups. In the steroid tapering group, participants will take MMF+TAC treatment without steroid for 1 year, and participants who stop steroid treatment without lupus flare will be randomly assigned to monotherapy with MMF or TAC. In the steroid maintenance group, participants will take MMF+TAC+steroid for 1 year, and participants without lupus flare will stop the use of steroid for 6 months. Participants without lupus flare after the stop of steroid will be randomly assigned to monotherapy with MMF or TAC.
CONDITIONS
Official Title
Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with systemic lupus erythematosus by 2019 ACR/EULAR criteria and lupus nephritis by ACR definition
- Achieved treatment targets with clinical remission and DORIS for at least 6 months, including urine protein ≤0.5g/day, stable or improved kidney function, clinical SLE Disease Activity Index score of 0 (except hypocomplementemia and anti-dsDNA antibody positivity), Physician Global Assessment score below 0.5, prednisone or equivalent steroid dose ≤5mg/day, stable immunosuppressant and antimalarial use, and no biological agent use
- Able to accept the treatment as determined by the physician
- Willing to participate, able to comply, and able to understand and sign informed consent before the study
You will not qualify if you...
- Presence of important organ dysfunction such as consciousness disorder, cognitive disorder, kidney dysfunction, heart failure (NYHA class 3 or 4), pulmonary arterial hypertension, or interstitial lung disease
- Active vital organ disease not meeting DORIS criteria, including neuropsychiatric lupus, active lupus nephritis, thrombocytopenia, hemolytic anemia, heart or gastrointestinal involvement
- Allergy or intolerance to mycophenolate mofetil or tacrolimus
- Acute or chronic infections needing treatment, including tuberculosis, hepatitis B or C, HIV, or cytomegalovirus
- Pregnancy or planning pregnancy
- Use of biological agents within 6 months before enrollment
- Any condition the researcher judges as preventing study completion or posing significant risk to the participant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
C
Can Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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