A Phase 4 interventional study of Cinacalcet HCl in Hyperparathyroidism; Secondary, Renal, sponsored by Kyowa Kirin China Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Kyowa Kirin China Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment
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:
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.
Administer Cinacalcet HCL to subjects whose iPTH\>900 pg/ml from 1st to 32nd week.
Drug: Cinacalcet HCl
Administer Cinacalcet HCL to subjects whose 600≤iPTH\<900 pg/ml from 1st to 32nd week.
Drug: Cinacalcet HCl
Administer Cinacalcet HCL to subjects whose 300≤iPTH\<600 pg/ml from 1st to 32nd week.
Drug: Cinacalcet HCl
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.
Also known as: Regpara
Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
blood test
Time frame: 32 weeks
The proportion of patients once reaching iPTH target during 1st~32nd week
blood test
Time frame: 32 weeks
The proportion of patients once reaching iPTH target during 33rd~52nd week
blood test
Time frame: 52 weeks
Compared with baseline data, the change of Ca × P at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the change of Ca × P at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
medication evaluation
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
medication evaluation
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
medication evaluation
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
medication evaluation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 weeks
The reasons of patients discontinuing Cinacalcet in 20-week real world
List presentation
Time frame: 20 weeks
Plan to share: Undecided
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Kyowa Kirin China Pharmaceutical Co., Ltd.