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

Primary Purpose

Hyperphosphatemia, Inflammation, Renal Disease

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral Multivitamin
Sponsored by
Nephrian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring End Stage Renal Disease, Inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Simi Valley Dialysis CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Outcomes

Primary Outcome Measures

To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.

Secondary Outcome Measures

To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population

Full Information

First Posted
February 2, 2009
Last Updated
February 2, 2009
Sponsor
Nephrian
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1. Study Identification

Unique Protocol Identification Number
NCT00834301
Brief Title
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
Official Title
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nephrian

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 dialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Inflammation, Renal Disease
Keywords
End Stage Renal Disease, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Multivitamin
Intervention Description
Oral Multivitamin
Primary Outcome Measure Information:
Title
To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Chow, PhD
Organizational Affiliation
Nephrian
Official's Role
Study Director
Facility Information:
Facility Name
Simi Valley Dialysis Center
City
Simi Valley
State/Province
California
ZIP/Postal Code
93063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kant Tucker, MD
Phone
805-433-7500
First Name & Middle Initial & Last Name & Degree
Kant Tucker, MD

12. IPD Sharing Statement

Learn more about this trial

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

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