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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00656032
Eligibility Criteria:
Inclusion Criteria:
* CKD and receiving hemodialysis for ≥ 3months
* Kt/V ≥ 1.2
* ≥ 18 years of age
* Medically stable
* AVF or PTFE dialysis access
* No acute inflammatory disease within 4 weeks prior to the study
* On stable dose of Paricalcitol for 4 weeks prior to the study
* iPTH value between 150 - 1500 within the past 3 months
* Ca \< 10.5
* PO4 \< 10
Exclusion Criteria:
* Pregnancy
* Intolerance to the study medication
* Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
* Type 1 Diabetes mellitus
* Uncontrolled Type 2 Diabetes mellitus (HbA1c \> 10)
* Hospitalization within 1 month prior to the study
* Malfunctioning arterial-venous vascular access (recirculation and/or blood flow \< 250 ml/min)
* Presence of hemodialysis catheter
* Patients receiving steroids and/or other immunosuppressive agents (\> 10 mg prednisone qd)
* BMI \< 25 and \> 45
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00656032
Study Brief:
Protocol Section:
NCT00656032