Secondary Hyperparathyroidism
Conditions
Brief summary
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
Interventions
DRUGSK-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 (24 weeks), with individual dose adjustment.
DRUGPlacebo
Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Sponsors
Sanwa Kagaku Kenkyusho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week. | 24 weeks | Assessed by laboratory test value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measured values and Changes from baseline in serum PTH | 24 weeks | Assessed by laboratory test value; unit of measure (pg/mL) |
| Measured values and Changes from baseline in Ca | 24 weeks | Assessed by laboratory test value; unit of measure (mg/dL) |
| Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point. | 24 weeks | Assessed by laboratory test value |
| Measured values and Changes from baseline in P | 24 weeks | Assessed by laboratory test value; unit of measure (mg/dL) |
| Measured values and Changes from baseline in serum Ca x P product | 24 weeks | Assessed by laboratory test value |
| Measured values and Changes from baseline in ionized Ca | 24 weeks | Assessed by laboratory test value; unit of measure (mEq/dL) |
Countries
Japan
Outcome results
None listed