Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT02216656
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
74 Years
Study:
NCT02216656
Study Brief:
Protocol Section:
NCT02216656