Immune Effects of Vitamin D in Hemodialysis Patients

Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Hemodialysis; End Stage Renal Disease; Inflammatory Response
• Intervention / Treatment: Drug: paricalcitol

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Yorkville Dialysis Center
    • New York, New York, United States, 10003
      • Irving Place Dialysis Center
    • New York, New York, United States, 10025
      • Upper Manhattan Dialysis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measurement of pro- and anti-inflammatory cytokines and inflammatory markers	first and second HD treatments for the 4 weeks of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
serum calcium level	24 hours after termination of second HD treatment in week 3 of study
serum phosphate level	24 hours after termination of second HD treatment in week 3 of study

Collaborators and Investigators

• Sponsor: Renal Research Institute
• Collaborators: Abbott
• Investigators: Principal Investigator: Nathan W Levin, MD, Renal Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: May 29, 2008
• First Posted (Estimate): May 30, 2008

Study Record Updates

• Last Update Posted (Estimate): May 13, 2009
• Last Update Submitted That Met QC Criteria: May 12, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Cardiovascular Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 223-04