Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
研究概览
简要总结
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
详细描述
This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 group. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.
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
- •Patients with age between 18-75 years.
- •Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.
排除标准
- •Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
- •New fracture in last 3 months.
- •Active system immunity diseases.
- •History of liver failure
- •History of intestinal malabsorption or chronic diarrhea
- •Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
- •Primary hyperparathyroidism
- •Treatment with cinacalcet or other calcimimetic within the past 6 months
- •Anticipated dialysis within 6 months after randomization
- •Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
- •Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
- •Current treatment with vitamin D 50,000 IU
- •Using glucocorticoid or immunosuppressive agents.
- •Acute renal dysfunction.
- •The expected live time is less than 2 years.
- •Pregnant or lactating woman.
- •Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- •Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
研究组 & 干预措施
Vitamin D2 Treatment
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
干预措施: Vitamin D2 (Drug)
1,25(OH)2 Vitamin D3
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
干预措施: 1,25(OH)2 Vit D3 (Drug)
结局指标
主要结局
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
时间窗: 24 months
The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
The Blood Levels of Calcium at the 24th Month of Following up.
时间窗: 24 months
The blood levels of calcium at the 24th month of following up will be detected.
The Blood Levels of Phosphorus at the 24th Month of Following up.
时间窗: 24 months
The blood levels of phosphorus at the 24th month of following up will be detected.
次要结局
- The Blood 25(OH)Vitamin D Level.(24 months)
- The Incidence Rate of Secondary Hyperparathyroidism.(24 months)
研究者
Dongliang Zhang, MD
Associate Professor
Capital Medical University