Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

April 21, 2022 updated by: Kyowa Kirin Co., Ltd.

A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis

The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

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.
404

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 3

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
      • Changsha, China
        • Research site_29
      • Dalian, China
        • Research site_34
      • Foshan, China
        • Research site_25
      • Guangzhou, China
        • Research site_22
      • Guangzhou, China
        • Research site_23
      • Guangzhou, China
        • Research site_30
      • Hefei, China
        • Research site_28
      • Nanjing, China
        • Research site_32
      • Nanjing, China
        • Research site_33
      • Shanghai, China
        • Research site_24
      • Shanghai, China
        • Research site_26
      • Shanghai, China
        • Research site_27
      • Wuxi, China
        • Research site_31
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research site_11
  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Research site_21
      • Daegu, Korea, Republic of
        • Research site_13
      • Daegu, Korea, Republic of
        • Research site_15
      • Goyang, Korea, Republic of
        • Research site_12
      • Incheon, Korea, Republic of
        • Research site_18
      • Seoul, Korea, Republic of
        • Research site_14
      • Seoul, Korea, Republic of
        • Research site_17
      • Seoul, Korea, Republic of
        • Research site_19
      • Seoul, Korea, Republic of
        • Research site_20
      • Ulsan, Korea, Republic of
        • Research site_16
  • Taiwan
      • Kaohsiung, Taiwan
        • Research site_2
      • Kaohsiung, Taiwan
        • Research site_3
      • Kaohsiung, Taiwan
        • Research site_5
      • Taichung, Taiwan
        • Research site_9
      • Tainan, Taiwan
        • Research site_4
      • Tainan, Taiwan
        • Research site_7
      • Taipei, Taiwan
        • Research site_10
      • Taipei, Taiwan
        • Research site_1
      • Taipei, Taiwan
        • Research site_6
      • Taipei, Taiwan
        • Research site_8

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Personally submitted written voluntary informed consent to participate in the study
  2. Aged ≧18 years at the time of consent
  3. Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
  4. Intact PTH level (centrally measured) of >300 pg/mL at screening
  5. Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening

Exclusion Criteria:

  1. Treatment with cinacalcet hydrochloride within 2 weeks before screening
  2. Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
  3. Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
  4. Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
  5. Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
  6. Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
  7. Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
  8. Uncontrolled hypertension and/or diabetes

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: KHK7580 1mg-12mg
Drug: KHK7580
oral administration
Active Comparator: Cinacalcet 25mg-100mg
Drug: Cinacalcet Hydrochloride
oral administration

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
Time Frame
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
Time Frame: Week 50- Week 52
Week 50- Week 52

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
Time Frame
Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Time Frame: Week 50- Week 52
Week 50- Week 52
Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Time Frame: Week 50- Week 52
Week 50- Week 52
Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Time Frame: Week 50- Week 52
Week 50- Week 52
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Time Frame: Week 50- Week 52
Week 50- Week 52
Intact PTH level
Time Frame: Week 50- Week 52
Week 50- Week 52
corrected serum Ca level
Time Frame: Week 50- Week 52
Week 50- Week 52
serum P level
Time Frame: Week 50- Week 52
Week 50- Week 52

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 Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kyowa Hakko Kirin China Pharmaceutical Co., LTD.
Kyowa Kirin Korea Co., Ltd.

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 9, 2019

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.
September 23, 2021

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 23, 2021

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).
January 29, 2019

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.
January 29, 2019

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.
January 30, 2019

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 25, 2022

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 21, 2022

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, 2022

More Information

Terms related to this study

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.
  • 7580-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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