Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

Completed · Phase 4

Conditions studied: Kidney Failure

In brief

Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. Vitamin D use in dialysis patients has been shown to have a survival benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for involvement of the vitamin D receptor in inflammation, this study is designed to look for an effect of paricalcitol on markers of inflammation in hemodialysis patients.

Key facts

Study ID

NCT00294866

Run by

Fresenius Medical Care North America

People needed

64

Starts

2006-03-01

Expected to finish

2008-01-01

Last updated by the study team

2010-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CKD and receiving hemodialysis for greater than or equal to 3 months
• Age greater than or equal to 18 years
• Medically stable
• AVF or PTFE dialysis access
• No acute inflammatory disease within 4 weeks prior to study
• On an average dose of 3 - 7 mcg of paricalcitol three times per week for 4 weeks prior to the study
• Two consecutive iPTH of 150-400 (biPTH 75 - 200) =/- 30% one week apart
• Ca <10.2 mg/dL; PO4 <7.0
• Kt/V greater than or equal to 1.2
• On no other interventional drugs/devices in the past 30 days

You may not qualify if…

• Currently receiving dialysis using a venous catheter access
• Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)
• Pregnancy
• Hospitalization within the last 4 weeks. -

Where it is running

• Southwest Nephrology — Evergreen Park, Illinois, United States
• Nephrology Center — Kalamazoo, Michigan, United States
• Nephrology Associates P.A. — West Orange, New Jersey, United States
• Delaware Valley Nephrology — Philadelphia, Pennsylvania, United States
• Nephrology Associates, PC — Nashville, Tennessee, United States
• Tyler Nephrology Associates — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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