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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Participants in steroid tapering group will take MMF+TAC during the first 18 months. After 18 months, participants without lupus flare will randomly stop MMF or TAC. Participants in steroid maintenance group will take MMF+TAC during the first 24 months. After 24 months, participants without lupus flare will randomly stop MMF or TAC.
Participants in steroid tapering group will take MMF+TAC during the first 18 months. After 18 months, participants without lupus flare will randomly stop MMF or TAC. Participants in steroid maintenance group will take MMF+TAC during the first 24 months. After 24 months, participants without lupus flare will randomly stop MMF or TAC.
Participants in steroid tapering group will stop taking glucocorticoid after the first 6 months. Participants in steroid maintenance group will consistently take glucocorticoid for 18 months, and stop the use of glucocorticoid after 18 months if they do not flare.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGThe 1-year flare rate of lupus nephritis participants who reach the treatment target and accept MMF+TAC remedy tapering steroid in the maintenance period.
If the DORIS (Definition of Remission In SLE) is not sustained, the patient is considered to have lupus flare. Lupus flare can be further evaluated according to SELENA-SLEDAI Flare Index (SFI). Lupus nephritis flare can be further evaluated as flare of proteinuria and flare of nephritis.
Time frame: 6th~18th month
The 1-year flare rate of lupus nephritis participants who accept MMF or TAC monotherapy.
If the DORIS (Definition of Remission In SLE) is not sustained, the patient is considered to have lupus flare.
Time frame: 18th~30th month
Lupus flare (as assessed by SLEDAI and PGA) in SLE patients during the maintenance period after steroid tapering.
Time frame: 6th~30th month
The changes of serum activity markers (anti-dsDNA antibody and C3 level) in SLE patients after steroid tapering.
Time frame: 6th~30th month
Proportion of SLE patients with irreversible organ damage (assessed by SLICC/SDI) after steroid tapering.
Time frame: 6th~30th month
Changes in carotid intima-media thickness after steroid tapering.
Time frame: 6th~30th month
Differences in medical charges between steroid tapering and steroid maintenance patients.
Obtain the information by questionnaire.
Time frame: 6th~30th month
Differences in health-related quality of life between steroid tapering and steroid maintenance patients.
Evaluate health-related quality of life by Short-Form Six-Dimension (SF-6D) health index. SF-6D includes 6 dimensions: physical functioning, role limitations, social functioning, pain, mental health, and vitality. The minimum total value is 0. The maximum total value is 1. Higher scores mean a better outcome.
Time frame: 6th~30th month
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