Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2026-03-02 @ 8:38 PM
Study NCT ID:
NCT03123406
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'CKD Hemodialysis Patients with SHPT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week', 'timeFrame': '20 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week', 'timeFrame': '32 weeks', 'description': 'blood test'}], 'secondaryOutcomes': [{'measure': 'Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week', 'timeFrame': '32 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week', 'timeFrame': '20 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week', 'timeFrame': '32 weeks', 'description': 'blood test'}, {'measure': 'The proportion of patients once reaching iPTH target during 1st~32nd week', 'timeFrame': '32 weeks', 'description': 'blood test'}, {'measure': 'The proportion of patients once reaching iPTH target during 33rd~52nd week', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the change of Ca × P at 20th week', 'timeFrame': '20 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the change of Ca × P at 32nd week', 'timeFrame': '32 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week', 'timeFrame': '20 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week', 'timeFrame': '32 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week', 'timeFrame': '20 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week', 'timeFrame': '32 weeks', 'description': 'blood test'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week', 'timeFrame': '32 weeks', 'description': 'medication evaluation'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week', 'timeFrame': '32 weeks', 'description': 'medication evaluation'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week', 'timeFrame': '32 weeks', 'description': 'medication evaluation'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': 'Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week', 'timeFrame': '32 weeks', 'description': 'medication evaluation'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '52 weeks', 'description': 'blood test'}, {'measure': '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', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': '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', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': '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', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': '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', 'timeFrame': '20 weeks', 'description': 'medication evaluation'}, {'measure': 'The reasons of patients discontinuing Cinacalcet in 20-week real world', 'timeFrame': '20 weeks', 'description': 'List presentation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cinacalcet', 'secondary hyperparathyroidism', 'calcimimetics', 'CKD-MBD'], 'conditions': ['Hyperparathyroidism; Secondary, Renal']}, 'descriptionModule': {'briefSummary': '1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;\n2. To explore the impact of Cinacalcet HCL using on the combined use of drugs;\n3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Parents/guardians must sign informed consent;\n\nMust be males or females whose age are 18 to 75 years old;\n\nClinical diagnosis of chronic kidney disease on maintenance hemodialysis with secondary hyperparathyroidism;\n\niPTH must be equal or higher than 300Pg/ml;\n\nMust not have received Calcimimetics(for example, Cinacalcet) within 6 months prior to enrollment;\n\nMust 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;\n\nOver 2-year life expectancy.\n\nExclusion Criteria:\n\n\\- Hypocalcemia \\[Corrected serum calcium level less than 2.1mmol/L(8.4mg/dL);\n\nHistory of gastrointestinal bleeding or peptic ulcer disease and possibility of deterioration or recurrence;\n\nSevere heart disease;\n\nEpilepsy risk or history of epilepsy;\n\nHypersensitivity to Cinacalcet;\n\nDrug abuse/addiction;\n\nPlan to receive renal transplantation within 52 weeks;\n\nPregnant or lactating women;\n\nPregnancy plan within 1 years, or no guarantee on taking effective contraceptive measures within 1 year after enrollment;\n\nParticipated in other clinical trials within 4 weeks prior to enrollment;\n\nReceived parathyroidectomy within 24 weeks prior to enrollment;\n\nInvestigator judgment that patients are not suitable to enroll.'}, 'identificationModule': {'nctId': 'NCT03123406', 'acronym': 'ACTIVE', 'briefTitle': 'Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'KKCN201601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe SHPT', 'description': 'Administer Cinacalcet HCL to subjects whose iPTH\\>900 pg/ml from 1st to 32nd week.', 'interventionNames': ['Drug: Cinacalcet HCl']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate SHPT', 'description': 'Administer Cinacalcet HCL to subjects whose 600≤iPTH\\<900 pg/ml from 1st to 32nd week.', 'interventionNames': ['Drug: Cinacalcet HCl']}, {'type': 'EXPERIMENTAL', 'label': 'Mild SHPT', 'description': 'Administer Cinacalcet HCL to subjects whose 300≤iPTH\\<600 pg/ml from 1st to 32nd week.', 'interventionNames': ['Drug: Cinacalcet HCl']}], 'interventions': [{'name': 'Cinacalcet HCl', 'type': 'DRUG', 'otherNames': ['Regpara'], 'description': '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.', 'armGroupLabels': ['Mild SHPT', 'Moderate SHPT', 'Severe SHPT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Zhihong Liu', 'role': 'STUDY_CHAIR', 'affiliation': 'Jinling Hospital, China'}, {'name': 'Zhaohui Ni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}, {'name': 'Zhangsuo Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}, {'name': 'Jiazhuang Lou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Guanqing Xiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Foshan"}, {'name': 'Li Hao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Anhui Medial University'}, {'name': 'Ping Fu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hopsital, Sichuan University'}, {'name': 'Yisheng Ling', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Hospital Xiamen University'}, {'name': 'Xuemei Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Shixiang Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}, {'name': 'Aihua Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'Xiaonong Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Jing Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}, {'name': 'Li Zuo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Aili Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Second Hospital'}, {'name': 'Guohua Ding', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hubei General Hospital'}, {'name': 'Jianying Niu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Yonghui Mao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Hospital'}, {'name': 'Qiang He', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sichuan Provincial People's Hospital"}, {'name': 'Chaosheng Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Wenzhou Medical University'}, {'name': 'Hong Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Xiangya Hospital of Central South University'}, {'name': 'Junwei Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Nanjing Medical University'}, {'name': 'Jianming Ye', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The First People's Hospital of Kunshan"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin China Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}