Secondary Hyperparathyroidism
Conditions
Brief summary
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
Interventions
DRUGPlacebo
Oral administration
DRUGKHK7580 low dose
Oral administration
DRUGKHK7580 middle dose
Oral administration
DRUGKHK7580 high dose
Oral administration
DRUGKRN1493
Oral administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have voluntarily consented to participate in this study * Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening * Subjects with an intact Parathyroid hormone of \>= 240 pg/mL at screening
Exclusion criteria
* Subjects with primary hyperparathyroidism * Subjects who have received cinacalcet hydrochloride within 2 weeks before screening * Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening. * Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening. * Subjects with uncontrolled hypertension and/or diabetes * Subjects with severe heart disease. * Subjects with severe hepatic dysfunction. * Subjects who have received any other investigational drug within 12 weeks before screening * Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percent changes in intact Parathyroid hormone levels from baseline | Up to 3 weeks | Percent changes in intact Parathyroid hormone levels from baseline to end of administration period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus. | Up to 3 weeks | Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period. |
| Safety | Up to 3 weeks | 1. Number and types of adverse events 2. laboratory tests 3. vital signs 4. 12-lead electrocardiogram 5. ophthalmological examination |
Countries
Japan
Outcome results
None listed