Hyperparathyroidism
Conditions
Keywords
patients, receiving, hemodialysis, Secondary
Brief summary
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis
Interventions
DRUGKHK7580
Oral administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening * intact PTH value ≥ 240 pg/mL at the screening * Corrected serum calcium ≥ 8.4 mg/dL at the screening
Exclusion criteria
* Patients with primary hyperparathyroidism * Patients who received cinacalcet within 2 weeks prior to the screening * Patients with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening * Patients who received parathyroidectomy and/or parathyroid intervention * Patients with uncontrolled hypertension and/or diabetes * Patients with severe heart disorder * Patients with severe hepatic disease * Patients who take investigational drug in other clinical trial within 12 weeks prior to the screening * Patients who have been judged ineligible to participate in the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination | For 19 weeks | The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profiles of pharmacokinetics | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period | Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed. |
| Profiles of pharmacodynamics | For 4-15 days after every dosing | intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin |
Countries
Japan
Outcome results
None listed