Immune Effects of Vitamin D in Hemodialysis Patients

NCT00686751 | Completed Phase 2 DMC

• 1 other identifier: 223-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

End Stage Renal Disease; Hemodialysis; Inflammatory Response; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• measurement of pro- and anti-inflammatory cytokines and inflammatory markers

  first and second HD treatments for the 4 weeks of the study

Secondary Outcomes (2)

• 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

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

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.

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renal Research Institute: lead
• Abbott: collaborator

Study Sites (3)

Irving Place Dialysis Center

New York, New York, 10003, United States

Location

Upper Manhattan Dialysis Center

New York, New York, 10025, United States

Location

Yorkville Dialysis Center

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Cardiovascular Diseases

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan W Levin, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: December 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 13, 2009

Record last verified: 2009-05

Locations

US (3)