Secondary Hyperparathyroidism
Conditions
Brief summary
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
Interventions
DRUGDose-adjusted SK-1403
SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment
Sponsors
Sanwa Kagaku Kenkyusho Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Average serum PTH\>240 pg/mL during 2 weeks 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 criteria
* Primary hyperparathyroidism * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive | 18 weeks | Assessed by laboratory test value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively | 18 weeks | Assessed by laboratory test value |
| Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product | 52 weeks | Assessed by laboratory test value |
Countries
Japan
Outcome results
None listed