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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01514851
Eligibility Criteria:
Inclusion Criteria:
* Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and \<11.0 mg/dL at 1 week after the initiation of the washout period.
* Out-patient
* Undergoing hemodialysis three times per week for at least previous 3 consecutive months
Exclusion Criteria:
* Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
* Corrected serum calcium level of \<7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after
* Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period
* Pregnant woman, or lactating mother
* Significant gastrointestinal disorders including known acute peptic ulcer
* Liver dysfunction
* History of cardiovascular or cerebrovascular diseases
* Requiring treatment for hypothyroidism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01514851
Study Brief:
Protocol Section:
NCT01514851