SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
NCT ID: NCT03626948
Last Updated: 2020-03-09
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
PHASE3
157 participants
INTERVENTIONAL
2018-09-13
2020-02-05
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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SK-1403
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.
SK-1403
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.
Interventions
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SK-1403
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.
Eligibility Criteria
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Inclusion Criteria
* Serum corrected Ca≥8.4 mg/dL at the screening
* Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Exclusion Criteria
* Severe liver disease
* Severe cardiac disease
* History or family history of long QT syndrome
* Malignant tumor
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* A history of severe drug allergy
20 Years
ALL
No
Sponsors
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Sanwa Kagaku Kenkyusho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Investigational site (there may be other sites in this country)
Tokyo, , Japan
Countries
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Other Identifiers
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AJ1003
Identifier Type: -
Identifier Source: org_study_id
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