Clinical trial NCT00294866: Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Keywords: End Stage Renal Disease
Inflammation
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2006-02-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary Outcome is a significant change in markers of inflammation to include:
timeFrame: 4 weeks
measure: CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Evergreen Park
country: United States
facility: Southwest Nephrology
state: Illinois
city: Kalamazoo
country: United States
facility: Nephrology Center
state: Michigan
city: West Orange
country: United States
facility: Nephrology Associates P.A.
state: New Jersey
city: Philadelphia
country: United States
facility: Delaware Valley Nephrology
state: Pennsylvania
city: Nashville
country: United States
facility: Nephrology Associates, PC
state: Tennessee
city: Tyler
country: United States
facility: Tyler Nephrology Associates
state: Texas
Study officials:
affiliation: Fresenius Medical Care North America
name: Mark R Kaplan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: