Status:
COMPLETED
Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
Lead Sponsor:
Fresenius Medical Care North America
Collaborating Sponsors:
Abbott
Conditions:
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 patient...
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 leve...
Eligibility Criteria
Inclusion
- 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
- Currently receiving dialysis using a venous catheter access
- Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)
- Pregnancy
- Hospitalization within the last 4 weeks. -
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00294866
Start Date
March 1 2006
End Date
January 1 2008
Last Update
April 8 2010
Active Locations (6)
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1
Southwest Nephrology
Evergreen Park, Illinois, United States, 60805
2
Nephrology Center
Kalamazoo, Michigan, United States, 49007
3
Nephrology Associates P.A.
West Orange, New Jersey, United States, 07052
4
Delaware Valley Nephrology
Philadelphia, Pennsylvania, United States, 19144