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Immune Effects of Vitamin D in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686751
First Posted: May 30, 2008
Last Update Posted: May 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by:
Renal Research Institute
  Purpose
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.

Condition Intervention Phase
End Stage Renal Disease Hemodialysis Inflammatory Response Cardiovascular Disease Drug: paricalcitol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • 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 Measures:
  • serum calcium level [ Time Frame: 24 hours after termination of second HD treatment in week 3 of study ]
  • serum phosphate level [ Time Frame: 24 hours after termination of second HD treatment in week 3 of study ]

Enrollment: 20
Study Start Date: December 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

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.

Drug: paricalcitol
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686751


Locations
United States, New York
Irving Place Dialysis Center
New York, New York, United States, 10003
Upper Manhattan Dialysis Center
New York, New York, United States, 10025
Yorkville Dialysis Center
New York, New York, United States, 10128
Sponsors and Collaborators
Renal Research Institute
Abbott
Investigators
Principal Investigator: Nathan W Levin, MD Renal Research Institute
  More Information

Responsible Party: Nathan Levin, MD, Renal Research Institute
ClinicalTrials.gov Identifier: NCT00686751     History of Changes
Other Study ID Numbers: 223-04
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: May 13, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents