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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00285467
Eligibility Criteria:
Inclusion Criteria:
* age 18 years old or older, male or female
* able to sign informed consent
* CKD stage 3 (GFR 30-59 ml/min) or stage 4 (15-29 ml/min)
* intact Parathyroid hormone level (iPTH) \> 100 pg/ml for stage 3 or iPTH \> 150 pg/ml for stage 4
* calcidiol levels ≤ 20 ng/ml
* ability to ambulate without assistance
Exclusion Criteria:
* intact PTH \> 400 pg/ml
* initial corrected Calcium \> 9.7 mg/dl
* initial serum Phosphorous \> 5.0 mg/dl
* initial standardized blood pressure of \> 160/100
* history of significant liver disease or cirrhosis
* anticipated requirement for dialysis in 6 months
* malabsorption, severe chronic diarrhea, or ileostomy
* no calcimimetic or active vitamin D therapy 30 days prior to enrollment
* use of digoxin, magnesium containing products, mineral oil, or cholestyramine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT00285467
Study Brief:
Protocol Section:
NCT00285467