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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT00752102
Eligibility Criteria:
Inclusion Criteria:
* CKD stages 3 or 4 (estimated glomerular filtration rate (eGFR) between 15 and 59)
* Diagnosis of secondary hyperparathyroidism, which is defined as:
* Elevated intact PTH (iPTH) as per KDIGO guidelines:
* CKD stage 3 (eGFR 30-59) or CKD stage 4 (eGFR 15-29) with iPTH \> Upper Limit of Normal for lab (6.8 pmol/L)
* Presence of Coronary Artery Calcium (CAC \> 0)
* Subject will be able to complete the study, to the best of his/her knowledge
Exclusion Criteria:
* iPTH \>1500 pg/ml
* Current or previous use of bisphosphonates
* History of parathyroidectomy or anticipated parathyroidectomy
* History of cinacalcet use
* History of a solid organ transplant or scheduled date for transplant surgery
* History of coronary revascularization (coronary artery bypass surgery or percutaneous intervention)
* History of coronary artifact (e.g. pacemaker, intracardiac defibrillator, artificial valve or biventricular leads)
* Active atrial fibrillation
* Weight greater than 300 pounds (due to limitations of equipment)
* HIV positive
* Current pregnancy (although pregnancy is very rare in the CKD population)
* Life expectancy less than two years as judged by primary physician
* Institutionalized patients (nursing home or prisoners)
* Language barrier or mental incapacity to consent
* Inability to swallow tablets or current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT00752102
Study Brief:
Protocol Section:
NCT00752102