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)

KKCN201601

1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT; 2. To explore the impact of Cinacalcet HCL using on the combined use of drugs; 3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.

2017-04-19

2019-04-20

2019-09-06

Completed

Early phase I

750

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'CKD Hemodialysis Patients with SHPT', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 750, 'type': 'ACTUAL'}}

2024-04-29