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OpenTrials
Completed

NCT Number: NCT00294866

Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

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.

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Key information

Conditions

Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southwest Nephrology, Evergreen Park, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Paricalcitol

Drug

Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.

Primary outcomes

  1. Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.

    Time frame: 4 weeks

Secondary outcomes

  1. Secondary Outcome is a significant change in markers of inflammation to include:

    Time frame: 4 weeks

  2. CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care North America

Industry

Collaborators

  • Abbott

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2006
Registry last updated
Apr 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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