Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
This study has been completed.
Sponsor:
Fresenius Medical Care North America
Collaborator:
Abbott
Information provided by:
Fresenius Medical Care North America
ClinicalTrials.gov Identifier:
NCT00294866
First received: February 17, 2006
Last updated: April 7, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure |
Drug: Paricalcitol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by Fresenius Medical Care North America:
Primary Outcome Measures:
- Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary Outcome is a significant change in markers of inflammation to include: [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 64 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Receive Paricalcitol
|
Drug: 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
|
Drug: Paricalcitol
Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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. -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294866
Locations
| United States, Illinois | |
| Southwest Nephrology | |
| Evergreen Park, Illinois, United States, 60805 | |
| United States, Michigan | |
| Nephrology Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, New Jersey | |
| Nephrology Associates P.A. | |
| West Orange, New Jersey, United States, 07052 | |
| United States, Pennsylvania | |
| Delaware Valley Nephrology | |
| Philadelphia, Pennsylvania, United States, 19144 | |
| United States, Tennessee | |
| Nephrology Associates, PC | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Tyler Nephrology Associates | |
| Tyler, Texas, United States, 75701 | |
Sponsors and Collaborators
Fresenius Medical Care North America
Abbott
Investigators
| Principal Investigator: | Mark R Kaplan, M.D. | Fresenius Medical Care North America |
More Information
No publications provided
| Responsible Party: | Mark Kaplan, M.D., Vice President of Clinical Research, Fresenius Medical Care North America |
| ClinicalTrials.gov Identifier: | NCT00294866 History of Changes |
| Other Study ID Numbers: | 2005002 |
| Study First Received: | February 17, 2006 |
| Last Updated: | April 7, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Fresenius Medical Care North America:
|
End Stage Renal Disease Inflammation |
Additional relevant MeSH terms:
|
Inflammation Renal Insufficiency Renal Insufficiency, Chronic Pathologic Processes Kidney Diseases Urologic Diseases Ergocalciferols |
Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013