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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01382212
Eligibility Criteria:
Inclusion Criteria:
* Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
* Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
* For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor \[VDR\] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:
* A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL
* A phosphorus value ≤ 6.5 mg/dL
* An intact parathyroid hormone (iPTH) value \> 300 pg/mL and less ≤ 2000 pg/mL
Exclusion Criteria:
* Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
* Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
* Subject has had a parathyroidectomy within 12 weeks prior to Screening
* Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
* Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
* Subject is receiving cinacalcet at the time of Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
16 Years
Study:
NCT01382212
Study Brief:
Protocol Section:
NCT01382212