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Clinical Trial Details

Trial ID: L1600
Source ID: NCT03123406
Associated Drug: Cinacalcet Hcl
Title: Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
Acronym: ACTIVE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hyperparathyroidism; Secondary, Renal
Interventions: DRUG: Cinacalcet HCl
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 750
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-04-19
Completion Date: 2019-09-06
Results First Posted:
Last Update Posted: 2024-04-29
Locations: Nanjing Jinling Hospital, Nanjing, Jiangsu, 210002, China
URL: https://clinicaltrials.gov/show/NCT03123406