- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822507
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
Conditions
Intervention / Treatment
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
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Changsha, China
- Research site_29
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Dalian, China
- Research site_34
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Foshan, China
- Research site_25
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Guangzhou, China
- Research site_22
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Guangzhou, China
- Research site_23
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Guangzhou, China
- Research site_30
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Hefei, China
- Research site_28
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Nanjing, China
- Research site_32
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Nanjing, China
- Research site_33
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Shanghai, China
- Research site_24
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Shanghai, China
- Research site_26
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Shanghai, China
- Research site_27
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Wuxi, China
- Research site_31
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Hong Kong, Hong Kong
- Research site_11
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Anyang, Korea, Republic of
- Research site_21
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Daegu, Korea, Republic of
- Research site_13
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Daegu, Korea, Republic of
- Research site_15
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Goyang, Korea, Republic of
- Research site_12
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Incheon, Korea, Republic of
- Research site_18
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Seoul, Korea, Republic of
- Research site_14
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Seoul, Korea, Republic of
- Research site_17
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Seoul, Korea, Republic of
- Research site_19
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Seoul, Korea, Republic of
- Research site_20
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Ulsan, Korea, Republic of
- Research site_16
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Kaohsiung, Taiwan
- Research site_2
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Kaohsiung, Taiwan
- Research site_3
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Kaohsiung, Taiwan
- Research site_5
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Taichung, Taiwan
- Research site_9
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Tainan, Taiwan
- Research site_4
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Tainan, Taiwan
- Research site_7
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Taipei, Taiwan
- Research site_10
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Taipei, Taiwan
- Research site_1
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Taipei, Taiwan
- Research site_6
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Taipei, Taiwan
- Research site_8
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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:
- Personally submitted written voluntary informed consent to participate in the study
- Aged ≧18 years at the time of consent
- Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
- Intact PTH level (centrally measured) of >300 pg/mL at screening
- Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening
Exclusion Criteria:
- Treatment with cinacalcet hydrochloride within 2 weeks before screening
- 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
- Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
- Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
- Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
- Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
- Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
- 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
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oral administration
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Active Comparator: Cinacalcet 25mg-100mg
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oral administration
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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
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Week 50- Week 52
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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
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Week 50- Week 52
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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
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Week 50- Week 52
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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
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Week 50- Week 52
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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
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Week 50- Week 52
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Intact PTH level
Time Frame: Week 50- Week 52
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Week 50- Week 52
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corrected serum Ca level
Time Frame: Week 50- Week 52
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Week 50- Week 52
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serum P level
Time Frame: Week 50- Week 52
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Week 50- Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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
- 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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