Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05916781
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-06-09
Brief Title:
Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus
Sponsor:
Chinese SLE Treatment And Research Group
Organization:
Chinese SLE Treatment And Research Group
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine whether mycophenolate mofetilMMF combined with tacrolimusTAC can maintain remission in patients with lupus nephritis LN who have reached treatment targets after steroid tapering The main questions 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 MMFTAC 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 MMFTACsteroid 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
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 MMFTAC 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 MMFTACsteroid 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
Detailed Description:
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 α005 two-sided 1-β090 non-inferiority value 15 the dropout rate 20 The sample size of each group should be 110 the 220 in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None