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Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

Primary Purpose

Kidney Failure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paricalcitol
Sponsored by
Fresenius Medical Care North America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure focused on measuring End Stage Renal Disease, Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Southwest Nephrology
  • Nephrology Center
  • Nephrology Associates P.A.
  • Delaware Valley Nephrology
  • Nephrology Associates, PC
  • Tyler Nephrology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

A

B

Arm Description

Receive Paricalcitol

Paricalcitol on hold

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary Outcome is a significant change in markers of inflammation to include:
CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P

Full Information

First Posted
February 17, 2006
Last Updated
April 7, 2010
Sponsor
Fresenius Medical Care North America
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00294866
Brief Title
Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fresenius Medical Care North America
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
End Stage Renal Disease, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Receive Paricalcitol
Arm Title
B
Arm Type
No Intervention
Arm Description
Paricalcitol on hold
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Intervention Description
Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.
Primary Outcome Measure Information:
Title
Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Secondary Outcome is a significant change in markers of inflammation to include:
Time Frame
4 weeks
Title
CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R Kaplan, M.D.
Organizational Affiliation
Fresenius Medical Care North America
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Nephrology
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Nephrology Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Nephrology Associates P.A.
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Delaware Valley Nephrology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States
Facility Name
Nephrology Associates, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tyler Nephrology Associates
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

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