Secondary Hyperparathyroidism
Conditions
Brief summary
To evaluate the safety and efficacy of treatment with SK-1403 for 52 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 (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 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 * A history of severe drug allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events or adverse drug reactions | 52 weeks | Number of participants with adverse events or adverse drug reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point | 52 weeks | Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point; Assessed by laboratory test value |
| Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product | 52 weeks | Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value |
Countries
Japan
Outcome results
None listed