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Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

This study has been completed.
Sponsor:
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
  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:

  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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Kidney Diseases
Pathologic Processes
Urologic Diseases
Ergocalciferols
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on November 19, 2014