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Immune Effects of Vitamin D in Hemodialysis Patients

Primary Purpose

End Stage Renal Disease, Hemodialysis, Inflammatory Response

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paricalcitol
Sponsored by
Renal Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient stable on chronic hemodialysis for more than 3 months.
  • PTH level between 150 - 800 pg/ml.
  • Ability to give informed consent.
  • Serum calcium levels (corrected for albumin level of 4.0 g/dL) less than 10.5 mg/dL for the last three consecutive measurements.
  • Serum Phosphorus levels between 2.5 and 7.0 mg/dL for the last three consecutive measurements.
  • Ca x P-Product of less than 75 mg2/dL2 in the last three consecutive measurements.

Exclusion Criteria:

  • Known active malignancy.
  • Liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal.
  • PTH levels between 150 pg/mL and 800 pg/mL.
  • Hypercalcemia or hypercalcemic episodes within the last 4 weeks.
  • Ca x P-Product more than 75 mg2/dL2 within the last 4 weeks.
  • Any clinical significant infections which are or have been treated with antibiotics within 6 weeks prior to start of the study.
  • Chronic viral infection (HIV, Hepatitis B or C).
  • Currently on immunosuppressive medication (steroids, cyclosporine, etc…).
  • Hematocrit less than 30 %.
  • History of blood disorders other than renal anemia.
  • Age of less than 18 years or more than 75 years.
  • Hypersensitivity to paricalcitol or any ingredient of the product.
  • Parathyroidectomy.
  • Participation in another study at the same time.

Sites / Locations

  • Irving Place Dialysis Center
  • Upper Manhattan Dialysis Center
  • Yorkville Dialysis Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

There is only one arm in this study. Each subject will be studied through 3 phases lasting a total of 4 weeks: Phase 1: administration of study medication at the end of hemodialysis treatment. Phase 2: no administration of study medication. Phase 3: administration of study medication at the beginning of hemodialysis.

Outcomes

Primary Outcome Measures

measurement of pro- and anti-inflammatory cytokines and inflammatory markers

Secondary Outcome Measures

serum calcium level
serum phosphate level

Full Information

First Posted
May 27, 2008
Last Updated
May 12, 2009
Sponsor
Renal Research Institute
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00686751
Brief Title
Immune Effects of Vitamin D in Hemodialysis Patients
Official Title
Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Renal Research Institute
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study to examine whether vitamin D can reduce the activation of the immune system during dialysis. When activated, the immune cells release certain substances, called cytokines, which can be measured from small blood samples. We want to study to what degree the immune system is activated during a regular dialysis treatment and whether the time point of vitamin D administration, either right before the start or right at the end of a dialysis treatment, has an impact on the activation of the immune system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis, Inflammatory Response, Cardiovascular Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
There is only one arm in this study. Each subject will be studied through 3 phases lasting a total of 4 weeks: Phase 1: administration of study medication at the end of hemodialysis treatment. Phase 2: no administration of study medication. Phase 3: administration of study medication at the beginning of hemodialysis.
Intervention Type
Drug
Intervention Name(s)
paricalcitol
Intervention Description
Dosage Form: Intravenous administration. Dosage: 0.01 micrograms/kilogram of body weight. Frequency: 2 HD treatments of each study week (depending on phase of study). Duration: 4 weeks.
Primary Outcome Measure Information:
Title
measurement of pro- and anti-inflammatory cytokines and inflammatory markers
Time Frame
first and second HD treatments for the 4 weeks of the study
Secondary Outcome Measure Information:
Title
serum calcium level
Time Frame
24 hours after termination of second HD treatment in week 3 of study
Title
serum phosphate level
Time Frame
24 hours after termination of second HD treatment in week 3 of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient stable on chronic hemodialysis for more than 3 months. PTH level between 150 - 800 pg/ml. Ability to give informed consent. Serum calcium levels (corrected for albumin level of 4.0 g/dL) less than 10.5 mg/dL for the last three consecutive measurements. Serum Phosphorus levels between 2.5 and 7.0 mg/dL for the last three consecutive measurements. Ca x P-Product of less than 75 mg2/dL2 in the last three consecutive measurements. Exclusion Criteria: Known active malignancy. Liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal. PTH levels between 150 pg/mL and 800 pg/mL. Hypercalcemia or hypercalcemic episodes within the last 4 weeks. Ca x P-Product more than 75 mg2/dL2 within the last 4 weeks. Any clinical significant infections which are or have been treated with antibiotics within 6 weeks prior to start of the study. Chronic viral infection (HIV, Hepatitis B or C). Currently on immunosuppressive medication (steroids, cyclosporine, etc…). Hematocrit less than 30 %. History of blood disorders other than renal anemia. Age of less than 18 years or more than 75 years. Hypersensitivity to paricalcitol or any ingredient of the product. Parathyroidectomy. Participation in another study at the same time.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan W Levin, MD
Organizational Affiliation
Renal Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irving Place Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Upper Manhattan Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Yorkville Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States

12. IPD Sharing Statement

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Immune Effects of Vitamin D in Hemodialysis Patients

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