Immune Effects of Vitamin D in Hemodialysis Patients
This study has been completed.
Information provided by:
Renal Research Institute
First received: May 27, 2008
Last updated: May 12, 2009
Last verified: May 2009
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.
End Stage Renal Disease
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2007 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- Participation in another study at the same time.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00686751
|Irving Place Dialysis Center
|New York, New York, United States, 10003 |
|Upper Manhattan Dialysis Center
|New York, New York, United States, 10025 |
|Yorkville Dialysis Center
|New York, New York, United States, 10128 |
Renal Research Institute
||Nathan W Levin, MD
||Renal Research Institute
||Nathan Levin, MD, Renal Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 27, 2008
||May 12, 2009
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 23, 2016
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Physiological Effects of Drugs
Bone Density Conservation Agents