Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
April 7, 2010 updated by: Fresenius Medical Care North America
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.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Evergreen Park, Illinois, United States, 60805
- Southwest Nephrology
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Michigan
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Kalamazoo, Michigan, United States, 49007
- Nephrology Center
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New Jersey
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West Orange, New Jersey, United States, 07052
- Nephrology Associates P.A.
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19144
- Delaware Valley Nephrology
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Tennessee
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Nashville, Tennessee, United States, 37205
- Nephrology Associates, PC
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Texas
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Tyler, Texas, United States, 75701
- Tyler Nephrology Associates
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
- Pregnancy
- Hospitalization within the last 4 weeks. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A
Receive Paricalcitol
|
Patients randomized to either receive Paricalcitol or have it held.
After 4 weeks they are switched to the opposite intervention.
|
|
No Intervention: B
Paricalcitol on hold
|
Patients randomized to either receive Paricalcitol or have it held.
After 4 weeks they are switched to the opposite intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Secondary Outcome is a significant change in markers of inflammation to include:
Time Frame: 4 weeks
|
4 weeks
|
|
CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark R Kaplan, M.D., Fresenius Medical Care North America
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
February 17, 2006
First Submitted That Met QC Criteria
February 17, 2006
First Posted (Estimate)
February 22, 2006
Study Record Updates
Last Update Posted (Estimate)
April 8, 2010
Last Update Submitted That Met QC Criteria
April 7, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.