Safety and Efficacy of Cholecalciferol Supplementation in Patients of Chronic Kidney Disease (CKD) with Vitamin D Deficiency and Secondary Hyperparathyroidism (SHPT)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number or percent of subjects achieving mean percent reductions of plasma iPTH of greater than equal to 30 percent from pre treatment baseline at the end of the study
研究概览
简要总结
Safety and Efficacy of Cholecalciferol Supplementation in Patients of Chronic Kidney Disease with Vitamin D Deficiency and Secondary Hyperparathyroidism Prospective open label single center study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age between 18 and 85 years 2 Those with an eGFR of greater than or equal to 15 and less than or equal to 59 mlmin1.73m2 CKD Grade 3 and 4 3 Serum total 25hydroxy D greater than or equal to 10 to less than or equal to 20 ng per ml 4 Plasma iPTH levels greater than or equal to 85 to less than 500 pg per ml 5 Serum Calcium of greater than or equal to 8.4 to less than 9.8 mg per dl 6 Serum Phosphorus of greater than or equal to 2 to less than 5 mg per dl 7 Patients are required to have language competency English Telugu or Hindi in order to complete the study related questionnaires which include the Beck Depression Inventory Questionnaire that measures characteristic attitudes and symptoms of depression 8 Normal Liver function test 9 A record will be made of the patients history and physical examination 10 Subject and legally acceptable representative LAR are able to attend all scheduled visits and to comply with all trial procedures 11 All patients will provide signed informed consent.
排除标准
- •1 Not available for follow-up 2 Allergic to or intolerant to the investigational medication 3 Fasting Spot urinary Ca:Cr ratio greater than 0.2 4 Nephrotic range proteinuria greater than equal to 3.5 g per 24h urine 5 History of parathyroidectomy or renal transplantation 6 Subjects taking greater than 1000 mg per day of elemental Ca 7 Subjects receiving supplementation with ergocalciferol or cholecalciferol 8 Any bone metabolism therapy with the exception of bisphosphonates that could potentially interfere with study endpoints is to be discontinued for the duration of the study and a 56 day pre treatment washout is to be imposed In the case of bisphosphonates, subjects had to be on a stable dose for greater than 6 months prior to enrolment and maintain that dose for study duration.
结局指标
主要结局
Number or percent of subjects achieving mean percent reductions of plasma iPTH of greater than equal to 30 percent from pre treatment baseline at the end of the study
时间窗: Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180
Number of subjects with any adverse drug reaction
时间窗: Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180
Number of subjects with serum 25HydroxyD levels of greater than equal to 150 ng per ml
时间窗: Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180
Number of subjects with serum Ca levels of greater than equal to 10.5 mg per dl
时间窗: Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180
Number of subjects with serum P of greater than 5.0 mg per dl
时间窗: Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180
次要结局
- Number or percentage of individuals with a 25hydroxy D levels of greater than equal to 30 ng per ml(Number or percentage of individuals requiring dose escalation after 3 months of treatment)
研究者
Dr D Sreebhushan Raju
Nizams Institute of Medical Sciences