Back to resultsEfficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT (ACTIVE)
Primary Purpose
Hyperparathyroidism; Secondary, Renal
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cinacalcet HCl
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism; Secondary, Renal focused on measuring cinacalcet, secondary hyperparathyroidism, calcimimetics, CKD-MBD
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.
Sites / Locations
- Nanjing Jinling Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Severe SHPT
Moderate SHPT
Mild SHPT
Arm Description
Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week.
Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week.
Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week.
Outcomes
Primary Outcome Measures
Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
blood test
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
blood test
Secondary Outcome Measures
Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
blood test
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
blood test
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
blood test
The proportion of patients once reaching iPTH target during 1st~32nd week
blood test
The proportion of patients once reaching iPTH target during 33rd~52nd week
blood test
Compared with baseline data, the change of Ca × P at 20th week
blood test
Compared with baseline data, the change of Ca × P at 32nd week
blood test
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
blood test
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
blood test
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
blood test
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
blood test
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
medication evaluation
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
medication evaluation
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
medication evaluation
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
medication evaluation
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
medication evaluation
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
medication evaluation
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
medication evaluation
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
medication evaluation
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
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
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
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
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
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
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
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
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
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
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
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
The reasons of patients discontinuing Cinacalcet in 20-week real world
List presentation
Full Information
NCT ID
NCT03123406
First Posted
March 29, 2017
Last Updated
March 15, 2020
Sponsor
Kyowa Kirin China Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03123406
Brief Title
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
Acronym
ACTIVE
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
April 20, 2019 (Actual)
Study Completion Date
September 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin China Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;
To explore the impact of Cinacalcet HCL using on the combined use of drugs;
To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism; Secondary, Renal
Keywords
cinacalcet, secondary hyperparathyroidism, calcimimetics, CKD-MBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
CKD Hemodialysis Patients with SHPT
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Severe SHPT
Arm Type
Experimental
Arm Description
Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week.
Arm Title
Moderate SHPT
Arm Type
Experimental
Arm Description
Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week.
Arm Title
Mild SHPT
Arm Type
Experimental
Arm Description
Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week.
Intervention Type
Drug
Intervention Name(s)
Cinacalcet HCl
Other Intervention Name(s)
Regpara
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
Description
blood test
Time Frame
20 weeks
Title
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
Description
blood test
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
Description
blood test
Time Frame
32 weeks
Title
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
Description
blood test
Time Frame
20 weeks
Title
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
Description
blood test
Time Frame
32 weeks
Title
The proportion of patients once reaching iPTH target during 1st~32nd week
Description
blood test
Time Frame
32 weeks
Title
The proportion of patients once reaching iPTH target during 33rd~52nd week
Description
blood test
Time Frame
52 weeks
Title
Compared with baseline data, the change of Ca × P at 20th week
Description
blood test
Time Frame
20 weeks
Title
Compared with baseline data, the change of Ca × P at 32nd week
Description
blood test
Time Frame
32 weeks
Title
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
Description
blood test
Time Frame
20 weeks
Title
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
Description
blood test
Time Frame
32 weeks
Title
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
Description
blood test
Time Frame
20 weeks
Title
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
Description
blood test
Time Frame
32 weeks
Title
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
Description
medication evaluation
Time Frame
20 weeks
Title
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
Description
medication evaluation
Time Frame
32 weeks
Title
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
Description
medication evaluation
Time Frame
20 weeks
Title
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
Description
medication evaluation
Time Frame
32 weeks
Title
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
Description
medication evaluation
Time Frame
20 weeks
Title
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
Description
medication evaluation
Time Frame
32 weeks
Title
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
Description
medication evaluation
Time Frame
20 weeks
Title
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
Description
medication evaluation
Time Frame
32 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
blood test
Time Frame
52 weeks
Title
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
Description
medication evaluation
Time Frame
20 weeks
Title
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
Description
medication evaluation
Time Frame
20 weeks
Title
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
Description
medication evaluation
Time Frame
20 weeks
Title
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
Description
medication evaluation
Time Frame
20 weeks
Title
The reasons of patients discontinuing Cinacalcet in 20-week real world
Description
List presentation
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu
Organizational Affiliation
Jinling Hospital, China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhaohui Ni
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhangsuo Liu
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiazhuang Lou
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guanqing Xiao
Organizational Affiliation
First People's Hospital of Foshan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Hao
Organizational Affiliation
The Second Hospital of Anhui Medial University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Fu
Organizational Affiliation
West China Hopsital, Sichuan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yisheng Ling
Organizational Affiliation
Zhongshan Hospital Xiamen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xuemei Li
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shixiang Wang
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aihua Zhang
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaonong Chen
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Chen
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Zuo
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aili Jiang
Organizational Affiliation
Tianjin Medical University Second Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guohua Ding
Organizational Affiliation
Hubei General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianying Niu
Organizational Affiliation
The Fifth People's Hospital of Shanghai, Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yonghui Mao
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qiang He
Organizational Affiliation
Sichuan Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chaosheng Chen
Organizational Affiliation
First Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Liu
Organizational Affiliation
Second Xiangya Hospital of Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junwei Yang
Organizational Affiliation
Second Affiliated Hospital of Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianming Ye
Organizational Affiliation
The First People's Hospital of Kunshan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
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