Expired Study
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Nashville, Tennessee 37232


Purpose:

The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.


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


NCT ID:

NCT00656032


Primary Contact:

Principal Investigator
Alp Ikizler, MD
Vanderbilt University


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37232
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 18, 2018

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