Immune Effects of Vitamin D in Hemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT00686751
First received: May 27, 2008
Last updated: May 12, 2009
Last verified: May 2009
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum calcium level [ Time Frame: 24 hours after termination of second HD treatment in week 3 of study ] [ Designated as safety issue: Yes ]
  • serum phosphate level [ Time Frame: 24 hours after termination of second HD treatment in week 3 of study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00686751

Locations
United States, New York
Upper Manhattan Dialysis Center
New York, New York, United States, 10025
Irving Place Dialysis Center
New York, New York, United States, 10003
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

No publications provided

Responsible Party: Nathan Levin, MD, Renal Research Institute
ClinicalTrials.gov Identifier: NCT00686751     History of Changes
Other Study ID Numbers: 223-04
Study First Received: May 27, 2008
Last Updated: May 12, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 30, 2014