Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

Fresenius Medical Care North America64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Kidney Failure

Interventions

ParicalcitolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. CKD and receiving hemodialysis for greater than or equal to 3 months 2. Age greater than or equal to 18 years 3. Medically stable 4. AVF or PTFE dialysis access 5. No acute inflammatory disease within 4 weeks prior to study 6. On an average dose of 3 - 7 mcg of paricalcitol three times per week for 4 weeks prior to the study 7. Two consecutive iPTH of 150-400 (biPTH 75 - 200) =/- 30% one week apart 8. Ca \<10.2 mg/dL; PO4 \<7.0 9. Kt/V greater than or equal to 1.2 10. On no other interventional drugs/devices in the past 30 days Exclusion Criteria: 1. Currently receiving dialysis using a venous catheter access 2. Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone) 3. Pregnancy 4. Hospitalization within the last 4 weeks. -

Locations (6)

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

Outcomes

Primary Outcomes

Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.

Time frame: 4 weeks

Secondary Outcomes

Secondary Outcome is a significant change in markers of inflammation to include:

Time frame: 4 weeks

CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P

Time frame: 4 weeks

Data from ClinicalTrials.gov

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