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 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT01578200
Eligibility Criteria:
Inclusion Criteria:
* hemodialysis patients with hyperphosphatemia who require phosphate binders
* hemodialysis for more than 3 months
* patients who have at least one calcification risk factor (elderly \> 65 years, postmenopausal woman, type 2 diabetes mellitus)
* intact-PTH \< or = 240pg/mL
* life expectancy \> 1 year
* with written informed consent
Exclusion Criteria:
* contraindications to lanthanum carbonate and calcium carbonate
* swallowing disorders
* severe GI disorders
* history of obstructed bowels
* history of IHD/stroke within 6 months before randomization
* NYHA classification Ⅲ-Ⅳ
* severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution
* require treatment of arrhythmia
* severe malnutrition
* malignancy of any type within the last five years
* peritoneal dialysis patients
* pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term
* ineligible patients according to the investigator's judgment
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01578200
Study Brief:
Protocol Section:
NCT01578200