Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Renal Flare
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy-proven lupus nephritis who experienced an episode of Asymptomatic Serological Flare (ASF) as defined by:
- •Increase in anti-dsDNA to >100 IU/mL, with or without drop in serum complement levels OR
- •Increase in anti-dsDNA to higher than the normal range and more than two times of the preceding value, with or without drop in serum complement levels
- •Absence of renal or systemic manifestation of SLE.
排除标准
- •Patients who cannot provide informed consent.
- •Patients whom the clinicians opined to have excessively high risk of infection or malignancy.
- •Patients who are pregnant or lactating.
研究组 & 干预措施
Pre-emptive Treatment (Prednisolone and/or AZA/MMF)
-
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.
-
Adjustment of the 2nd agent would be as follows:
-
For patients who receive AZA <75mg/day; increase the dose of AZA to 75 mg/day.
-
For patients who receive MMF <1g/day, increase the dose of MMF to 1g/day.
干预措施: Pre-emptive increase of immunosuppressive treatments (Procedure)
Pre-emptive Treatment (Prednisolone and/or AZA/MMF)
-
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.
-
Adjustment of the 2nd agent would be as follows:
-
For patients who receive AZA <75mg/day; increase the dose of AZA to 75 mg/day.
-
For patients who receive MMF <1g/day, increase the dose of MMF to 1g/day.
干预措施: Prednisolone and/or AZA/MMF (Drug)
结局指标
主要结局
Renal Flare
时间窗: Within 24 months
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
次要结局
- Infections requiring hospitalization(24 months)
- Extra-renal flares(24 months)
- Serum creatinine levels(24 months)
- Changes in anti-dsDNA(24 months)
- Changes in C3(24 months)
- Changes in Hba1c(24 months)
- Changes in fasting glucose(24 months)
- Changes in LDL levels(24 months)