Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hyperparathyroidism; Secondary, Renal

Intervention / Treatment
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* Drug: Cinacalcet HCl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CKD Hemodialysis Patients with SHPT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe SHPT<br>Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week. | Drug: Cinacalcet HCl<br>* 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.<br>* Other names: Regpara;|
| Experimental: Moderate SHPT<br>Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week. | Drug: Cinacalcet HCl<br>* 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.<br>* Other names: Regpara;|
| Experimental: Mild SHPT<br>Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week. | Drug: Cinacalcet HCl<br>* 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.<br>* Other names: Regpara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cinacalcet, secondary hyperparathyroidism, calcimimetics, CKD-MBD