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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02833857
Eligibility Criteria:
Inclusion Criteria:
* Subject's parent has provided informed consent and subject has provided assent
* Children Age 2 to less than 18 years
* Diagnosed with chronic kidney disease
* Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
* Weighing at least 7 kg
* Laboratory results within specified range.
Exclusion Criteria:
* Currently receiving treatment in another investigation device or drug study
* Subject has received cinacalcet therapy within 30 days
* History of prolongation QT interval
* Subject is taking any medications that are on the QT prolongation medication list
* Electrocardiograph (ECG) measurements within specified range.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT02833857
Study Brief:
Protocol Section:
NCT02833857