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 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT00750295
Eligibility Criteria:
Inclusion Criteria:
* Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
* A controlled serum phosphorus.
* Constant dose of concomitant medications.
* Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.
Exclusion Criteria:
* Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
* Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
* Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00750295
Study Brief:
Protocol Section:
NCT00750295