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

Completed

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • 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

      • 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
        • Research site_11
      • 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
      • 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

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
Intervention / Treatment
Experimental: KHK7580 1mg-12mg
oral administration
Active Comparator: Cinacalcet 25mg-100mg
oral administration

What is the study measuring?

Primary Outcome Measures

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

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.

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)

April 9, 2019

Primary Completion (Actual)

September 23, 2021

Study Completion (Actual)

September 23, 2021

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

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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