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.

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. -