NCT00294866

Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

An Open Label, Multi-Center Study of the Effect of Paricalcitol on Markers of Inflammation in Patients With Stage 5 Chronic Kidney Disease on Hemodialysis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Fresenius Medical Care North America · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with ESRD have a high incidence of acute phase inflammation. Studies have shown that C-reactive Protein (CRP) and interleukin-6 (IL-6) are excellent biomarkers for inflammation, and high levels are predictive of cardiovascular morbidity and mortality in this population. Both uremia and the dialysis process itself contribute to this inflammatory state. It is our hypothesis that paricalcitol therapy decreases the biomarkers of inflammation which may have implications for future studies of morbidity and mortality in this population.

Conditions

• Kidney Failure

Interventions

Type	Name	Description
DRUG	Paricalcitol	Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-02-22
• Last updated: 2010-04-08

Locations

6 sites across 1 country: United States