Status:
COMPLETED
Phase 3 Study of SK-1403
Lead Sponsor:
Sanwa Kagaku Kenkyusho Co., Ltd.
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
Eligibility Criteria
Inclusion
- Serum PTH\>240 pg/mL at the screening
- Serum corrected Ca≧8.4 mg/dL at the screening
- Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Exclusion
- Primary hyperparathyroidism
- Severe liver disease
- Severe Cardiac disease
- History or family history of long QT syndrome
- Malignant tumor
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- History of severe drug allergy
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2019
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03801980
Start Date
January 21 2019
End Date
December 21 2019
Last Update
March 9 2020
Active Locations (1)
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1
Investigational site (there may be other sites in this country)
Tokyo, Japan