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

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

Interventions

DRUG

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.

Sponsors & Collaborators

• Kyowa Kirin China Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Zhihong Liu · Jinling Hospital, China

• Zhaohui Ni · RenJi Hospital

• Zhangsuo Liu · The First Affiliated Hospital of Zhengzhou University

• Jiazhuang Lou · The First Affiliated Hospital with Nanjing Medical University

• Guanqing Xiao · First People's Hospital of Foshan

• Li Hao · The Second Hospital of Anhui Medial University

• Ping Fu · West China Hopsital, Sichuan University

• Yisheng Ling · Zhongshan Hospital Xiamen University

• Xuemei Li · Peking Union Medical College Hospital

• Shixiang Wang · Beijing Chao Yang Hospital

• Aihua Zhang · Peking University Third Hospital

• Xiaonong Chen · Ruijin Hospital

• Jing Chen · Huashan Hospital

• Li Zuo · Peking University People's Hospital

• Aili Jiang · Tianjin Medical University Second Hospital

• Guohua Ding · Hubei General Hospital

• Jianying Niu · Fudan University

• Yonghui Mao · Beijing Hospital

• Qiang He · Sichuan Provincial People's Hospital

• Chaosheng Chen · First Affiliated Hospital of Wenzhou Medical University

• Hong Liu · Second Xiangya Hospital of Central South University

• Junwei Yang · Second Affiliated Hospital of Nanjing Medical University

• Jianming Ye · The First People's Hospital of Kunshan

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-19

Primary Completion

2019-04-20

Completion

2019-09-06

Countries

• China

Study Locations