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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT00502268
Eligibility Criteria:
Inclusion Criteria:
1. Patient age \> 18 and \< 80 years of age
2. Patients receiving outpatient hemodialysis for \> 3 or \<24 months duration
3. Patients must have baseline coronary calcification defined as at one ROI (regions of interest with \>130 Hounsfield units) in 1 or more coronary vessels
4. Patients must have a stable dose of phosphate binder for 30 days prior to study enrollment
Exclusion Criteria:
1. Patients intact PTH \< 100 or \> 1000 pg/ml
2. Patients on peritoneal dialysis
3. Patients with a previous parathyroidectomy
4. Patients with dry weight \> 300 lbs
5. Patients with chronic atrial flutter or fibrillation
6. Patients receiving chronic coumadin therapy
7. Patients with known allergies to contrast dyes
8. Patients receiving current Cinacalcet therapy or during previous 30 days
9. Patients unable to take Metoprolol therapy
10. Patients with resting heart rate \>100 and unresponsive to beta blockade
11. Patients with known pregnancy or unwilling to use contraception during the course of the study
12. Patients unable to tolerate the confines of CT scanner
13. Patients with a renal transplant within the previous 5 years
14. Patients with known aluminum toxicity
15. Patients undergoing recent PTCA or CABG within the previous 12 months
16. Patients with ESRD secondary to Sarcoidosis
17. Patients unwilling to use Selevamer as a primary phosphate binder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00502268
Study Brief:
Protocol Section:
NCT00502268