Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
NCT ID: NCT02143271
Last Updated: 2015-03-05
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
PHASE1
13 participants
INTERVENTIONAL
2014-05-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KHK7580
KHK7580
Oral administration
Interventions
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KHK7580
Oral administration
Eligibility Criteria
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Inclusion Criteria
* Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
* intact parathyroid hormone value ≥ 240 pg/mL at the screening
* Corrected serum calcium ≥ 8.4 mg/dL at the screening
Exclusion Criteria
* Patients who received cinacalcet within 2 weeks prior to the screening
* Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
* Patients who underwent parathyroidectomy and/or parathyroid intervention
* Patients with uncontrolled hypertension and/or diabetes
* Patients with severe heart disorder
* Patients with severe hepatic disease
* Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening
* Patients who have been judged ineligible to participate in the study by the 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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Kyowa Hakko Kirin
Tokyo, , Japan
Countries
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Other Identifiers
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7580-004
Identifier Type: -
Identifier Source: org_study_id
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