The optimal management of asymptomatic serological reactivation (ASR) in lupus nephritis (LN) patients remained undefined. This project aims to investigate the impact of pre-emptive treatment on disease relapse in LN patients who experienced ASR.
LN patients who presented with ASR \[defined as 1) increase in anti-dsDNA \>100 IU/mL , with or without drop in serum complement; or 2) increase in anti-dsDNA to higher than the normal range and \>2 times of the preceding value, with or without drop in serum complement; and 3) Absence of renal or systemic manifestations of SLE) will be randomized to receive pre-emptive increase in immunosuppression or had their current immunosuppressive therapies unchanged. Patients will be followed at 4-, 12-, 24-wk and then every 12 weeks up to 24 months to monitor for renal or extra-renal relapses. Bloods and urine will be collected for measurement of renal and serological parameters, and also B cell signatures. Primary outcomes: Renal Flare (denoted as proteinuria \>1g/D; presence of urinary RBC \>30 hpf/RBC casts, or increase in SCr \>15% and positive anti-dsDNA) Secondary outcomes: * Safety \& tolerability of pre-emptive increase of immunosuppressive treatments * Extra-renal flares * Renal function at 24 months * Changes in serological parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
1. Increase prednisolone to 0.4-0.5 mg/kg/day; taper by 5 mg every 2 weeks to reach 15mg/day; then further reduce by 2.5 mg every 2 week and aim to reach 5-7.5 mg/day after 12 weeks. 2. Adjustment of the 2nd agent would be as follows: 1. For patients who receive AZA \<75mg/day; increase the dose of AZA to 75 mg/day. 2. For patients who receive MMF \<1g/day, increase the dose of MMF to 1g/day.
Prednisolone and/or AZA/MMF
Queen Mary Hospital, Hong Kong
Hong Kong, Hong Kong
United Christian Hospital
Hong Kong, Hong Kong
Renal Flare
A composite endpoint denoted by proteinuria \>1g/day, presence of urinary RBC \>30/hpf or RBC casts, or increase in serum creatinine by 15% compared with baseline, and anti-DNA antibody titre above the upper limit of normal
Time frame: Within 24 months
Infections requiring hospitalization
Time frame: 24 months
Extra-renal flares
Time frame: 24 months
Serum creatinine levels
Time frame: 24 months
Changes in anti-dsDNA
Time frame: 24 months
Changes in C3
Time frame: 24 months
Changes in Hba1c
Time frame: 24 months
Changes in fasting glucose
Time frame: 24 months
Changes in LDL levels
Time frame: 24 months
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