NCT04994080Unknown3 期
A Multi-center, Randomized, Double-blind, Parallel Grouping, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Paricalcitol Soft Capsules in the Treatment of Secondary Hyperparathyroidism in Subjects With Stage 3 and Stage 4 Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 84
- 主要终点
- Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under care of physician at least 2 months for CKD
- •Not on active Vitamin D and Calcimimetic therapy for at least 4 weeks prior
- •If taking phosphate binders, on a stable regimen at least 4 weeks prior
- •For entry into Pretreatment Phase:
- •iPTH at least 120 pg/mL GFR of 15-60 mL/min and no dialysis expected for at least 6 months
- •For entry into Treatment Phase:
- •Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL) 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL
排除标准
- •Subjects who had Primary hyperparathyroidism;
- •Subjects with a history of acute renal failure;
- •Subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms;
- •Subjects with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically meaningful arrhythmia;
- •Subjects with serum albumin < 30g/L, serum hemaoglobin < 85g/L, or serum transaminase higher than 2.5 times the upper limit of nomal;
- •Subjects with a history of malignancy;
- •Subjects who plan to undergo surgery during the study period;
- •Subjects with a history active granulomatous diseases;
- •Subject with a history of alcohol abuse and drug abuse;
- •Human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab) or Treponema pallidum antibody (TP-Ab) are positive;
- •Subjects who are allergic to the test drug and its ingredients or excipients;
- •Subjects who combined with systemic or systemic diseases that are not suitable for clinical trials;
- •Subjects who have participated in clinical trials of other drugs or devices;
研究组 & 干预措施
Treatment group A/B
Experimental
干预措施: Paricalcitol (Drug)
Treatment group C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.
时间窗: 0-24 weeks
次要结局
- The change value in blood calcium from baseline;(0-24 weeks)
- The change value of 24-hour urine phosphorus from baseline;(0-24 weeks)
- The change value of 24-hour creatinine clearance rate from baseline;(0-24 weeks)
- The change value of eGFR from baseline;(0-24 weeks)
- The change value in urine calcium/creatinine ratio from baseline.(0-24 weeks)
- The value of iPTH for each visit(0-24 weeks)
- The change from baseline of iPTH for each visit(0-24 weeks)
- The change percentage of iPTH for each visit;(0-24 weeks)
- The proportion of subjects whose iPTH has been reduced by more than 30% from baseline at least 4 consecutive times;(0-24 weeks)
- The change value in blood phosphorus from baseline;(0-24 weeks)
- The change value in calcium-phosphorus product from baseline;(0-24 weeks)
- The change value of 24-hour urine calcium from baseline;(0-24 weeks)
研究者
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