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

April 25, 2024 updated by: Kyowa Kirin China Pharmaceutical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
Time Frame: 20 weeks
blood test
20 weeks
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
Time Frame: 32 weeks
blood test
32 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
Time Frame: 32 weeks
blood test
32 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
Time Frame: 20 weeks
blood test
20 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
Time Frame: 32 weeks
blood test
32 weeks
The proportion of patients once reaching iPTH target during 1st~32nd week
Time Frame: 32 weeks
blood test
32 weeks
The proportion of patients once reaching iPTH target during 33rd~52nd week
Time Frame: 52 weeks
blood test
52 weeks
Compared with baseline data, the change of Ca × P at 20th week
Time Frame: 20 weeks
blood test
20 weeks
Compared with baseline data, the change of Ca × P at 32nd week
Time Frame: 32 weeks
blood test
32 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
Time Frame: 20 weeks
blood test
20 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
Time Frame: 32 weeks
blood test
32 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
Time Frame: 20 weeks
blood test
20 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
Time Frame: 32 weeks
blood test
32 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
Time Frame: 20 weeks
medication evaluation
20 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
Time Frame: 32 weeks
medication evaluation
32 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
Time Frame: 20 weeks
medication evaluation
20 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
Time Frame: 32 weeks
medication evaluation
32 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
Time Frame: 20 weeks
medication evaluation
20 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
Time Frame: 32 weeks
medication evaluation
32 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
Time Frame: 20 weeks
medication evaluation
20 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
Time Frame: 32 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 20 weeks
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
Time Frame: 20 weeks
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
Time Frame: 20 weeks
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
Time Frame: 20 weeks
medication evaluation
20 weeks
The reasons of patients discontinuing Cinacalcet in 20-week real world
Time Frame: 20 weeks
List presentation
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyowa Kirin China Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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