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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

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

NCT ID

NCT00834301

First Posted

February 2, 2009

Last Updated

February 2, 2009

Sponsor

Nephrian

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

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

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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