Skip to main content
OpenTrials
Completed

NCT Number: NCT00686751

Immune Effects of Vitamin D in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Renal Disease Cardiovascular Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Inflammatory Response Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Irving Place Dialysis Center, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paricalcitol

Drug

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 outcomes

  1. 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 outcomes

  1. serum calcium level

    Time frame: 24 hours after termination of second HD treatment in week 3 of study

  2. serum phosphate level

    Time frame: 24 hours after termination of second HD treatment in week 3 of study

Sponsors and collaborators

Lead sponsor

Renal Research Institute

Other

Collaborators

  • Abbott

Registry information

Official study title

Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
May 30, 2008
Registry last updated
May 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.