Immune Effects of Vitamin D in Hemodialysis Patients
This study has been completed.
Sponsor:
Renal Research Institute
Collaborator:
Abbott
Information provided by:
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT00686751
First received: May 27, 2008
Last updated: May 12, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
End Stage Renal Disease Hemodialysis Inflammatory Response Cardiovascular Disease |
Drug: paricalcitol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients |
Resource links provided by NLM:
Further study details as provided by Renal Research Institute:
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 ]
| Enrollment: | 20 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686751
Locations
| United States, New York | |
| Upper Manhattan Dialysis Center | |
| New York, New York, United States, 10025 | |
| Irving Place Dialysis Center | |
| New York, New York, United States, 10003 | |
| Yorkville Dialysis Center | |
| New York, New York, United States, 10128 | |
Sponsors and Collaborators
Renal Research Institute
Abbott
Investigators
| Principal Investigator: | Nathan W Levin, MD | Renal Research Institute |
More Information
No publications provided
| Responsible Party: | Nathan Levin, MD, Renal Research Institute |
| ClinicalTrials.gov Identifier: | NCT00686751 History of Changes |
| Other Study ID Numbers: | 223-04 |
| Study First Received: | May 27, 2008 |
| Last Updated: | May 12, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Vitamin D |
Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 21, 2013