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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 64
- Locations
- 6
- Primary Endpoint
- Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Currently receiving dialysis using a venous catheter access
- •Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)
- •Hospitalization within the last 4 weeks. -
Arms & Interventions
A
Receive Paricalcitol
Intervention: Paricalcitol (Drug)
B
Paricalcitol on hold
Intervention: Paricalcitol (Drug)
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:(4 weeks)
- CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P(4 weeks)