Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the percentage change of proteinuia
研究概览
简要总结
The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.
详细描述
Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75 years
- •clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis
- •proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month
- •estimated glomerular filtration rate (eGFR)>60ml/min/1/73m2
- •corticosteroid and immunosuppressive agents withdrawal for at least 6 months
- •normal blood pressure
- •serum intact parathyroid hormone (iPTH) level >20pg/mL
- •corrected serum calcium level < or = 2.55 mmol/L
- •serum phosphorus level < or = 1.68 mmol/L
- •24 hours urinary calcium excretion level < or = 7.5 mmol
- •not receive treatment of vitamin D or its analogue within 6 months
- •willigness to give written consent and comply with the study protocol
排除标准
- •history of sensitivity or allergy to calcitriol or other vitamin D analogs
- •pregnancy, lactating women
- •history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
- •history of malignancy
- •history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases
- •patients receiving drugs contains of calcium
- •patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption
- •participation in any other trials within 1 month
- •history of non-compliance
研究组 & 干预措施
Calcitriol
General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks.
干预措施: Calcitriol (Drug)
结局指标
主要结局
the percentage change of proteinuia
时间窗: 24 weeks
次要结局
- the proportion of patients achieving at least a 15% decrease in proteinuria(24 weeks)
研究者
Jing Chen
Professor, PhD., MD, Renal Division
Huashan Hospital