Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- overall clinical response
研究概览
简要总结
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 with informed consent.
- •Fulfill the revised American College of Rheumatology criteria for SLE
- •Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
- •Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
- •NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine <15% above the base-line value.
- •Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.
排除标准
- •Abnormal liver function tests
- •Hepatitis B surface antigen or hepatitis C antibody positive
- •Receiving NSAID or other agents known to influence urinary
- •Protein excretion
- •Allergic or intolerant to macrolide antibiotics or tacrolimus
研究组 & 干预措施
advagraf
Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
干预措施: Long-acting tacrolimus (Advagraf, Astellas Pharma) (Drug)
结局指标
主要结局
overall clinical response
时间窗: 6 months
complete response is defined as urinary protein \< 0.5 g/day, with normal urinary sediment, normal serum albumin, and serum creatinine \< 15% above the base-line value. Partial response is defined as urinary protein between 0.6 and 2.9 g/day, with a serum albumin \> 30 g/dL, and stable renal function. No response is defined as urinary protein \> 3 g/day or a value of 0.6 to 2.9 g/day but serum albumin \< 30 g/dL, an increase in serum creatinine ≥ 50 µmol/l or 15% above the base-line value, or the discontinuation of treatment due to side effects.
次要结局
- renal function(6 months)
- change in SLEDAI score(6 months)
- 24-hour urinary protein excretion(6 months)
- development of lupus flare (renal or non-renal)(6 months)
研究者
Cheuk-Chun SZETO
Professor
Chinese University of Hong Kong