Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
201 participants
INTERVENTIONAL
2014-07-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Plascebo
Placebo
Oral administration
KHK7580 low dose
KHK7580 low dose
Oral administration
KHK7580 middle dose
KHK7580 middle dose
Oral administration
KHK7580 high dose
KHK7580 high dose
Oral administration
KRN1493
KRN1493
Oral administration
Interventions
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Placebo
Oral administration
KHK7580 low dose
Oral administration
KHK7580 middle dose
Oral administration
KHK7580 high dose
Oral administration
KRN1493
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
* Subjects with an intact Parathyroid hormone of \>= 240 pg/mL at screening
Exclusion Criteria
* Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
* Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
* Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
* Subjects with uncontrolled hypertension and/or diabetes
* Subjects with severe heart disease.
* Subjects with severe hepatic dysfunction.
* Subjects who have received any other investigational drug within 12 weeks before screening
* Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
20 Years
74 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Tokyo, , Japan
Countries
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Other Identifiers
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7580-005
Identifier Type: -
Identifier Source: org_study_id
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