NCT03123406已完成4 期
A Multi-center Study Evaluating Efficacy and Safety of Cinacalcet Hydrochloride(HCL) in Calcium, Phosphorus and Intact Parathyroid Hormone(iPTH) Serum Levels in Chinese Chronic Kidney Disease(CKD) Hemodialysis(HD) Patients With Mild, Moderate and Severe Secondary Hyperparathyroidism(SHPT)
Kyowa Kirin China Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2017年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
研究概览
简要总结
- To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;
- To explore the impact of Cinacalcet HCL using on the combined use of drugs;
- To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Parents/guardians must sign informed consent;
- •Must be males or females whose age are 18 to 75 years old;
- •Clinical diagnosis of chronic kidney disease on maintenance hemodialysis with secondary hyperparathyroidism;
- •iPTH must be equal or higher than 300Pg/ml;
- •Must not have received Calcimimetics(for example, Cinacalcet) within 6 months prior to enrollment;
- •Must have been on maintenance hemodialysis 3 times weekly (TIW) for at least 3 months(12 weeks) prior to enrollment and must be expected to remain on hemodialysis for the duration of the study;
- •Over 2-year life expectancy.
排除标准
- •Hypocalcemia [Corrected serum calcium level less than 2.1mmol/L(8.4mg/dL);
- •History of gastrointestinal bleeding or peptic ulcer disease and possibility of deterioration or recurrence;
- •Severe heart disease;
- •Epilepsy risk or history of epilepsy;
- •Hypersensitivity to Cinacalcet;
- •Drug abuse/addiction;
- •Plan to receive renal transplantation within 52 weeks;
- •Pregnant or lactating women;
- •Pregnancy plan within 1 years, or no guarantee on taking effective contraceptive measures within 1 year after enrollment;
- •Participated in other clinical trials within 4 weeks prior to enrollment;
- •Received parathyroidectomy within 24 weeks prior to enrollment;
- •Investigator judgment that patients are not suitable to enroll.
研究组 & 干预措施
Severe SHPT
Experimental
Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week.
干预措施: Cinacalcet HCl (Drug)
Moderate SHPT
Experimental
Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week.
干预措施: Cinacalcet HCl (Drug)
Mild SHPT
Experimental
Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week.
干预措施: Cinacalcet HCl (Drug)
结局指标
主要结局
Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
时间窗: 20 weeks
blood test
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
时间窗: 32 weeks
blood test
次要结局
- Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week(32 weeks)
- Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week(20 weeks)
- Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week(32 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching iPTH target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period(52 weeks)
- Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week(32 weeks)
- The proportion of patients once reaching iPTH target during 1st~32nd week(32 weeks)
- Compared with baseline data, the change of Ca × P at 20th week(20 weeks)
- Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week(20 weeks)
- Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week(20 weeks)
- The proportion of patients once reaching iPTH target during 33rd~52nd week(52 weeks)
- Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week(20 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching Ca target at 52nd week who continue Cinacalcet treatment after 20-week real world period(52 weeks)
- The dose change of diphosphonic acid salts which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period(20 weeks)
- Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week(20 weeks)
- Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week(32 weeks)
- Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week(20 weeks)
- Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week(32 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching Ca target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period(52 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching P target at 52nd week who continue Cinacalcet treatment after 20-week real world period(52 weeks)
- The dose change of calcium agents which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period(20 weeks)
- Compared with baseline data, the change of Ca × P at 32nd week(32 weeks)
- Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week(20 weeks)
- Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week(32 weeks)
- Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week(32 weeks)
- Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week(32 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching Ca × P target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period(52 weeks)
- The reasons of patients discontinuing Cinacalcet in 20-week real world(20 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching iPTH target at 52nd week who continue Cinacalcet treatment during 20-week real world period(52 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching P target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period(52 weeks)
- Compared with the data at 32nd week, the proportional change of patients reaching Ca × P target at 52nd week who continue Cinacalcet treatment after 20-week real world period(52 weeks)
- The dose change of phosphate binders which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period(20 weeks)
- The dose change of vitamin D and its analogues which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period(20 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving HemodialysisSecondary HyperparathyroidismNCT00446329Papageorgiou General Hospital15
已完成
3 期
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular EventsSecondary HyperparathyroidismChronic Kidney DiseaseNCT00345839Amgen3,883
终止
不适用
Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney TransplantRenal TransplantHypophosphatemiaNCT01011114Montefiore Medical Center40
已完成
2 期
To check the efficacy of calcium hydroxide, triple antibiotic paste and metapex in treatment of infected immature teethCTRI/2018/05/014310none30
已完成
不适用
Clinical efficacy of intravenous calcium-sensing receptor agonist (etelcalcetide hydrochloride) for secondary hyperparathyroidismEnd-stage renal diseaseJPRN-UMIN000027408Saitama Tsukinomori Clinic32