Status:
COMPLETED
Immune Effects of Vitamin D in Hemodialysis Patients
Lead Sponsor:
Renal Research Institute
Collaborating Sponsors:
Abbott
Conditions:
End Stage Renal Disease
Hemodialysis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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, wh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00686751
Start Date
December 1 2004
End Date
September 1 2007
Last Update
May 13 2009
Active Locations (3)
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1
Irving Place Dialysis Center
New York, New York, United States, 10003
2
Upper Manhattan Dialysis Center
New York, New York, United States, 10025
3
Yorkville Dialysis Center
New York, New York, United States, 10128