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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT00123461
Eligibility Criteria:
Inclusion Criteria:
* Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4
* Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL
* CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min
Exclusion Criteria:
* Serum cCa \> 9.5 mg/dL
* Serum P \> 4.6 mg/dL
* Abnormal liver functions
* Anticipated requirement for maintenance hemodialysis
* Use of active vitamin D sterol therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00123461
Study Brief:
Protocol Section:
NCT00123461