Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT

NCT ID: NCT03123406

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-19
• Study Completion Date: 2019-09-06

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.

Conditions

Hyperparathyroidism; Secondary, Renal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe SHPT

Administer Cinacalcet HCL to subjects whose iPTH\>900 pg/ml from 1st to 32nd week.

Group Type: EXPERIMENTAL

Cinacalcet HCl

Intervention Type: DRUG

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.

Moderate SHPT

Administer Cinacalcet HCL to subjects whose 600≤iPTH\<900 pg/ml from 1st to 32nd week.

Group Type: EXPERIMENTAL

Cinacalcet HCl

Intervention Type: DRUG

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.

Mild SHPT

Administer Cinacalcet HCL to subjects whose 300≤iPTH\<600 pg/ml from 1st to 32nd week.

Group Type: EXPERIMENTAL

Cinacalcet HCl

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Regpara

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin China Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhihong Liu

Role: STUDY_CHAIR

Jinling Hospital, China

Zhaohui Ni

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Zhangsuo Liu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Jiazhuang Lou

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Guanqing Xiao

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Foshan

Li Hao

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medial University

Ping Fu

Role: PRINCIPAL_INVESTIGATOR

West China Hopsital, Sichuan University

Yisheng Ling

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital Xiamen University

Xuemei Li

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Shixiang Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Aihua Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Xiaonong Chen

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Jing Chen

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Li Zuo

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Aili Jiang

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Second Hospital

Guohua Ding

Role: PRINCIPAL_INVESTIGATOR

Hubei General Hospital

Jianying Niu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Yonghui Mao

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Qiang He

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Chaosheng Chen

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

Hong Liu

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Junwei Yang

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Nanjing Medical University

Jianming Ye

Role: PRINCIPAL_INVESTIGATOR

The First People's Hospital of Kunshan

Locations

Nanjing Jinling Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

KKCN201601

Identifier Type: -

Identifier Source: org_study_id