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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe SHPT | Experimental | Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week. |
|
| Moderate SHPT | Experimental | Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week. |
|
| Mild SHPT | Experimental | Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinacalcet HCl | Drug | Administer Cinacalcet HCL to all subjects from 1st to 32nd week. Subjects choose to buy and take Cinacalcet HCL in real-world period from 33rd to 52nd week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week | blood test | 20 weeks |
| Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week | blood test | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week | blood test | 32 weeks |
| Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Zhihong Liu | Jinling Hospital, China | Study Chair |
| Zhaohui Ni | RenJi Hospital | Principal Investigator |
| Zhangsuo Liu | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Jiazhuang Lou | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Guanqing Xiao | First People's Hospital of Foshan | Principal Investigator |
| Li Hao | The Second Hospital of Anhui Medial University | Principal Investigator |
| Ping Fu | West China Hopsital, Sichuan University | Principal Investigator |
| Yisheng Ling | Zhongshan Hospital Xiamen University | Principal Investigator |
| Xuemei Li | Peking Union Medical College Hospital | Principal Investigator |
| Shixiang Wang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Jinling Hospital | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D009362 | Neoplasm Metastasis |
| D006962 | Hyperparathyroidism, Secondary |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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CKD Hemodialysis Patients with SHPT
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|
blood test
| 20 weeks |
| Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week | blood test | 32 weeks |
| The proportion of patients once reaching iPTH target during 1st~32nd week | blood test | 32 weeks |
| The proportion of patients once reaching iPTH target during 33rd~52nd week | blood test | 52 weeks |
| Compared with baseline data, the change of Ca × P at 20th week | blood test | 20 weeks |
| Compared with baseline data, the change of Ca × P at 32nd week | blood test | 32 weeks |
| Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week | blood test | 20 weeks |
| Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week | blood test | 32 weeks |
| Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week | blood test | 20 weeks |
| Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week | blood test | 32 weeks |
| Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week | medication evaluation | 20 weeks |
| Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week | medication evaluation | 32 weeks |
| Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week | medication evaluation | 20 weeks |
| Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week | medication evaluation | 32 weeks |
| Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week | medication evaluation | 20 weeks |
| Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week | medication evaluation | 32 weeks |
| Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week | medication evaluation | 20 weeks |
| Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week | medication evaluation | 32 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 | blood test | 52 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 | blood test | 52 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 | blood test | 52 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 | blood test | 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 | blood test | 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 | blood test | 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 | blood test | 52 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 | blood test | 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 | medication evaluation | 20 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 | medication evaluation | 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 | medication evaluation | 20 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 | medication evaluation | 20 weeks |
| The reasons of patients discontinuing Cinacalcet in 20-week real world | List presentation | 20 weeks |
| Beijing Chao Yang Hospital |
| Principal Investigator |
| Aihua Zhang | Peking University Third Hospital | Principal Investigator |
| Xiaonong Chen | Ruijin Hospital | Principal Investigator |
| Jing Chen | Huashan Hospital | Principal Investigator |
| Li Zuo | Peking University People's Hospital | Principal Investigator |
| Aili Jiang | Tianjin Medical University Second Hospital | Principal Investigator |
| Guohua Ding | Hubei General Hospital | Principal Investigator |
| Jianying Niu | Fudan University | Principal Investigator |
| Yonghui Mao | Beijing Hospital | Principal Investigator |
| Qiang He | Sichuan Provincial People's Hospital | Principal Investigator |
| Chaosheng Chen | First Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Hong Liu | Second Xiangya Hospital of Central South University | Principal Investigator |
| Junwei Yang | Second Affiliated Hospital of Nanjing Medical University | Principal Investigator |
| Jianming Ye | The First People's Hospital of Kunshan | Principal Investigator |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |