Immune Effects of Vitamin D in Hemodialysis Patients

Cardiovascular Disease Clinical Trial

Official title:

Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686751
• Other study ID #: 223-04
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: May 12, 2009
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: May 2009
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• End Stage Renal Disease
• Hemodialysis
• Inflammatory Response
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Irving Place Dialysis Center	New York	New York
United States	Upper Manhattan Dialysis Center	New York	New York
United States	Yorkville Dialysis Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Renal Research Institute	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of pro- and anti-inflammatory cytokines and inflammatory markers		first and second HD treatments for the 4 weeks of the study	No
Secondary	serum calcium level		24 hours after termination of second HD treatment in week 3 of study	Yes
Secondary	serum phosphate level		24 hours after termination of second HD treatment in week 3 of study	Yes