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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00888069
Eligibility Criteria:
Inclusion Criteria:
* Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
* Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
* Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
* Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
* 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 15 ng/mL and lower than 30 ng/mL
* Hemoglobin level greater than or equal to 10 g/dL
Exclusion Criteria:
* Has nephrotic range proteinuria
* Has liver disease or significant hepatic dysfunction
* Is taking Cytochrome P450 3A4 inhibitors or inducers
* Has adult history of kidney stones and dysphagia
* Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
* Currently on dialysis
* Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00888069
Study Brief:
Protocol Section:
NCT00888069