Status:
UNKNOWN
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
Lead Sponsor:
Nephrian
Conditions:
Hyperphosphatemia
Inflammation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dia...
Eligibility Criteria
Inclusion
- End stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections
- Serum phosphorous level \> 5 mg/dl
- Stable phosphate binder regimen for 2 week prior to enrollment
- Stable dose of Vitamin D for 4 weeks prior to enrollment
- Stable calcimimetic dose for 4 week prior to enrollment
Exclusion
- patients who are pregnant
- patients who have pre existing thrombocytopenia defined as a platelet count of \<100 x 109/L
- abnormal LFTs
- baseline CRP \> 15 g/dl
- known sensitivity to any of the active ingredients
- patients who are currently enrolled in a clinical trial, or who have been in a clinical trial in the last six months
- are currently taking any immunosuppressive medications
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00834301
Start Date
January 1 2009
End Date
September 1 2009
Last Update
February 3 2009
Active Locations (1)
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1
Simi Valley Dialysis Center
Simi Valley, California, United States, 93063