Clinical Trial Details

NCT ID: NCT00834301
Date Last Changed: February 2, 2009

Overview

Research Study Summary

A clinical trial to evaluate treatments using Oral Multivitamin for patients with Hyperphosphatemia, Inflammation or Renal Disease

Research Study Title

An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients

Purpose

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 dialysis.

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Recruitment Details

Phase
2
Gender
Both Male and Female
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Nephrian
Duration
8 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years to 80 Years

Inclusion Criteria:

  • 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 Criteria:

  • 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

Site Locations (1)

Country State City Zip Facility and Contact
United States California Simi Valley 93063 Simi Valley Dialysis Center
Kant Tucker, MD
805-433-7500

Kant Tucker, MD
Principal Investigator

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