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

NCT03123406 | Completed Phase 4

• 1 other identifier: KKCN201601
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;
2. 2.To explore the impact of Cinacalcet HCL using on the combined use of drugs;
3. 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

Keywords

cinacalcet; secondary hyperparathyroidism; calcimimetics; CKD-MBD

Outcome Measures

Primary Outcomes (2)

• Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week

  blood test

  20 weeks

• Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week

  blood test

  32 weeks

Secondary Outcomes (32)

• Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week

  32 weeks

• Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week

  20 weeks

• Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week

  32 weeks

• The proportion of patients once reaching iPTH target during 1st~32nd week

  32 weeks

• The proportion of patients once reaching iPTH target during 33rd~52nd week

  52 weeks

Study Arms (3)

Severe SHPT

EXPERIMENTAL

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

Drug: Cinacalcet HCl

Moderate SHPT

EXPERIMENTAL

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

Drug: Cinacalcet HCl

Mild SHPT

EXPERIMENTAL

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

Drug: Cinacalcet HCl

Interventions

Cinacalcet HCl 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.

Also known as: Regpara

Mild SHPT; Moderate SHPT; Severe SHPT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Kyowa Kirin China Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanjing Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary; Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Zhihong Liu

  Jinling Hospital, China

  STUDY CHAIR

• Zhaohui Ni

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Zhangsuo Liu

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Jiazhuang Lou

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Guanqing Xiao

  First People's Hospital of Foshan

  PRINCIPAL INVESTIGATOR

• Li Hao

  The Second Hospital of Anhui Medial University

  PRINCIPAL INVESTIGATOR

• Ping Fu

  West China Hopsital, Sichuan University

  PRINCIPAL INVESTIGATOR

• Yisheng Ling

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

• Xuemei Li

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Shixiang Wang

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

• Aihua Zhang

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Xiaonong Chen

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Jing Chen

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Li Zuo

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Aili Jiang

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

• Guohua Ding

  Hubei General Hospital

  PRINCIPAL INVESTIGATOR

• Jianying Niu

  Fudan University

  PRINCIPAL INVESTIGATOR

• Yonghui Mao

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

• Qiang He

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Chaosheng Chen

  First Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Hong Liu

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Junwei Yang

  Second Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Jianming Ye

  The First People's Hospital of Kunshan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: CKD Hemodialysis Patients with SHPT

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 21, 2017
• Study Start: April 19, 2017
• Primary Completion: April 20, 2019
• Study Completion: September 6, 2019
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

CN (1)