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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT02549404
Eligibility Criteria:
Inclusion Criteria:
* Personally submitted written voluntary informed consent to participate in the study
* Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
* Intact PTH level of \> 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)
Exclusion Criteria:
* Change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
* Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
* Severe heart disease;
* Severe hepatic dysfunction;
* Uncontrolled hypertension and/or diabetes;
* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
* Primary hyperparathyroidism;
* Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02549404
Study Brief:
Protocol Section:
NCT02549404