Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility (recruitment rate and protocol adherence)
研究概览
简要总结
There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age at least 18 years
- •diagnosis of SLE by ACR criteria
- •diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV)
- •currently on prednisolone (5 to 20 mg/day)
- •in partial or complete remission for at least 3 months
排除标准
- •currently pregnant
- •in end-stage renal failure
- •receiving corticosteroids for an indication other than lupus nephritis
研究组 & 干预措施
1
Long-term low-dose prednisolone (5 - 7.5 mg/day)
干预措施: prednisolone (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility (recruitment rate and protocol adherence)
时间窗: 12 months
次要结局
- 1) time to major renal and non-renal relapses of SLE 2) time to minor relapses of SLE 3) health related quality of life 4) adverse events/side-effects 5) accrual of SLE related organ damage 6) renal function(24 months)