Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time to failure
研究概览
简要总结
OBJECTIVES:
Evaluate the efficacy of alternate day prednisone versus daily fish oil supplements in slowing or preventing the decline in renal function in children, adolescents, and young adults with moderate to severe immunoglobulin A nephropathy.
详细描述
PROTOCOL OUTLINE: This is randomized, double blind, placebo controlled, multicenter study.
Patients are randomized into one of three treatment arms: placebo, prednisone, or fish oil. The placebo arm is further randomized to receive either fish oil placebo capsules or prednisone placebo tablets.
Arm I: Patients receive placebo tablets or capsules for 2 years. Arm II: Patients receive a tapering regimen of prednisone tablets administered every other day for 2 years in the absence of unacceptable toxicity.
Arm III: Patients receive fish oil capsules daily for 2 years. Patients may also receive enalapril for hypertension. Patients are followed every 3 months for 3 years after treatment.
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
- — 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
omega-3 fatty acids
Omega 3 fatty acid Omacor
干预措施: omega-3 fatty acids (Drug)
Placebo
Placebo for prednisone or fatty acid
干预措施: Placebo (Drug)
Prednisone
Tapering regimen of alternate-day prednisone tablets (Deltasone)
干预措施: prednisone (Drug)
结局指标
主要结局
Time to failure
时间窗: Up to 5 years after randomization
Time to failure was defined as the interval until the eGFR fell to \<60% of baseline value.
次要结局
未报告次要终点