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

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)

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.

Study Overview

• Status: Completed
• Conditions: Hyperparathyroidism; Secondary, Renal
• Intervention / Treatment: Drug: Cinacalcet HCl

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe SHPT; Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week.	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.; Other Names: Regpara
Experimental: Moderate SHPT; Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week.	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.; Other Names: Regpara
Experimental: Mild SHPT; Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week.	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.; Other Names: Regpara

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week	blood test	32 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week	blood test	20 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week	blood test	32 weeks
The proportion of patients once reaching iPTH target during 1st~32nd week	blood test	32 weeks
The proportion of patients once reaching iPTH target during 33rd~52nd week	blood test	52 weeks
Compared with baseline data, the change of Ca × P at 20th week	blood test	20 weeks
Compared with baseline data, the change of Ca × P at 32nd week	blood test	32 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week	blood test	20 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week	blood test	32 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week	blood test	20 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week	blood test	32 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week	medication evaluation	20 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week	medication evaluation	32 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week	medication evaluation	20 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week	medication evaluation	32 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week	medication evaluation	20 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week	medication evaluation	32 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week	medication evaluation	20 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week	medication evaluation	32 weeks
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	blood test	52 weeks
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	blood test	52 weeks
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	blood test	52 weeks
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	blood test	52 weeks
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	blood test	52 weeks
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	blood test	52 weeks
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	blood test	52 weeks
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	blood test	52 weeks
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	medication evaluation	20 weeks
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	medication evaluation	20 weeks
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	medication evaluation	20 weeks
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	medication evaluation	20 weeks
The reasons of patients discontinuing Cinacalcet in 20-week real world	List presentation	20 weeks

Collaborators and Investigators

• Sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: 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, The Fifth People's Hospital of Shanghai, 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; Study Chair: Zhihong Liu, Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): April 20, 2019
• Study Completion (Actual): September 6, 2019

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cinacalcet; secondary hyperparathyroidism; calcimimetics; CKD-MBD
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Calcium-Regulating Hormones and Agents; Calcimimetic Agents; Cinacalcet
• Other Study ID Numbers: KKCN201601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No