Clinical trial NCT03123406: Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperparathyroidism; Secondary, Renal
Keywords: cinacalcet
secondary hyperparathyroidism
calcimimetics
CKD-MBD
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CKD Hemodialysis Patients with SHPT
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
timeFrame: 32 weeks
Secondary outcomes:
measure: Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
timeFrame: 32 weeks
measure: Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
timeFrame: 32 weeks
measure: The proportion of patients once reaching iPTH target during 1st~32nd week
timeFrame: 32 weeks
measure: The proportion of patients once reaching iPTH target during 33rd~52nd week
timeFrame: 52 weeks
measure: Compared with baseline data, the change of Ca × P at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the change of Ca × P at 32nd week
timeFrame: 32 weeks
measure: Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
timeFrame: 32 weeks
measure: Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
timeFrame: 32 weeks
measure: Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
timeFrame: 32 weeks
measure: Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
timeFrame: 32 weeks
measure: Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
timeFrame: 32 weeks
measure: Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
timeFrame: 20 weeks
measure: Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
timeFrame: 32 weeks
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
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
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
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
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
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
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
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
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
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
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
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
measure: The reasons of patients discontinuing Cinacalcet in 20-week real world
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Zhihong Liu
role: STUDY_CHAIR
affiliation: RenJi Hospital
name: Zhaohui Ni
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Zhangsuo Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jiazhuang Lou
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Foshan
name: Guanqing Xiao
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Anhui Medial University
name: Li Hao
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hopsital, Sichuan University
name: Ping Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Hospital Xiamen University
name: Yisheng Ling
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Xuemei Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chao Yang Hospital
name: Shixiang Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Aihua Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Xiaonong Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Jing Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Li Zuo
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Second Hospital
name: Aili Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei General Hospital
name: Guohua Ding
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jianying Niu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: Yonghui Mao
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Provincial People's Hospital
name: Qiang He
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Chaosheng Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Xiangya Hospital of Central South University
name: Hong Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Nanjing Medical University
name: Junwei Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Kunshan
name: Jianming Ye
role: PRINCIPAL_INVESTIGATOR
References: