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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT00792857
Eligibility Criteria:
Inclusion Criteria:
* Body mass index between 18 and 40
* On maintenance hemodialysis three times per week
* Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
* Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
* Visit 1: Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
* Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
* Visit 2: Serum iPTH value greater than 300 pg/mL
* Visit 2: Serum Ca x P product less than 56 \[mg/dl\]2
* Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study
Exclusion Criteria:
* Taking cytochrome P450 3A inhibitors and/or inducers
* Abnormal liver functions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00792857
Study Brief:
Protocol Section:
NCT00792857