Treatment of Primary Minimal Change Nephropathy: a Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Remission
研究概览
简要总结
Traditionally MCN is treated with a high dose of prednisolone, which induces remission in 60-90% of patients. Prednisolone treatment contains numerous side effects and the current dose is empiric. Given the lack of efficacy evidence and the risk associated with the currently accepted treatment regimen there is a need to characterize the outcome in MCN further, and to establish new, and potentially less toxic treatment regimens.
The aim is to examine if treatment with reduced dose of prednisolone in combination with activated vitamin D is as effective as standard high dose prednisolone in achieving remission and preventing relapse in MCN, and if reduced dose prednisolone is associated with fewer side effects compared to standard dose. Furthermore, the study will examine the influence of prednisolone metabolism on the efficacy and side effects of prednisolone in the treatment of MCN.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven minimal change nephropathy
- •If earlier minimal change: No relapse in 5 years, and earlier only treated with prednisolone
- •Nephrotic syndrome
- •Age more than 18 years
排除标准
- •Cancer except from basal cells carcinoma
- •Lymphoproliferative disease
- •Pregnancy
- •eGFR < 30 ml/min/1,73m2 (CKD-EPI)
- •No danish language
- •No ability to give informed prove
研究组 & 干预措施
High dose prednisolone
Prednisolone 1 mg/kg/day
干预措施: Prednisolone (Drug)
Alfacalcidol and low dose prednisolone
Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day
干预措施: Prednisolone (Drug)
Alfacalcidol and low dose prednisolone
Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day
干预措施: Alfacalcidol (Drug)
结局指标
主要结局
Remission
时间窗: 4 to 16 weeks
Time from treatment to remission and the frequency of patients reaching remission on treatment
次要结局
- Relapse(4 weeks to 1 year after remission)
- Concentration of Prednisolone in saliva(4 weeks after initiating prednisolone treatment)
- Side effects to treatment(4 weeks to 1 year after remission)
- Rates of genetic polymorphism, including HLA variations(Blood test at baseline)