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An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease

Primary Purpose

Anemia of Chronic Disease

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ESS (medical food/drug)
Sponsored by
Targeted Medical Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia of Chronic Disease

Eligibility Criteria

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

Inclusion Criteria:

  1. M/F patients 18 years old and over, non-pregnant/lactating
  2. Hemoglobin < 10 female,<11 male
  3. Ferritin > upper limit of normal for lab indicative of chronic anemia
  4. Anemia of chronic disease
  5. Crt. < 3.0

Exclusion Criteria:

  1. Currently taking other amino acid formulations.
  2. Pregnant or unwilling to use adequate birth control for the duration of the study.
  3. Excessive alcohol or illicit drug use.
  4. Unwilling or unable to sign informed consent.
  5. Myocardial infarction within the last 6 months.
  6. Patients ever having taken or currently taking an erythropoietin medication.
  7. Iron deficiency (add criteria).
  8. On dialysis.
  9. Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years.
  10. Liver cirrhosis (add criteria).

Sites / Locations

  • Targeted Medical Pharma

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ESS

Arm Description

Prescription medical food erythropoietin stimulating system

Outcomes

Primary Outcome Measures

Hemoglogin/Hematocrit

Secondary Outcome Measures

Red blood cell count
Reticulocyte count
IGF-1

Full Information

First Posted
April 30, 2013
Last Updated
April 30, 2013
Sponsor
Targeted Medical Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01846689
Brief Title
An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease
Official Title
An Open-label Trial of an Erythropoietin Stimulating System to Determine Increased Red Blood Cell Production in Subjects Diagnosed With Anemia of Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Targeted Medical Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESS
Arm Type
Experimental
Arm Description
Prescription medical food erythropoietin stimulating system
Intervention Type
Drug
Intervention Name(s)
ESS (medical food/drug)
Intervention Description
Prescription medical food erythropoietin stimulating system
Primary Outcome Measure Information:
Title
Hemoglogin/Hematocrit
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Red blood cell count
Time Frame
28 Days
Title
Reticulocyte count
Time Frame
28 days
Title
IGF-1
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: M/F patients 18 years old and over, non-pregnant/lactating Hemoglobin < 10 female,<11 male Ferritin > upper limit of normal for lab indicative of chronic anemia Anemia of chronic disease Crt. < 3.0 Exclusion Criteria: Currently taking other amino acid formulations. Pregnant or unwilling to use adequate birth control for the duration of the study. Excessive alcohol or illicit drug use. Unwilling or unable to sign informed consent. Myocardial infarction within the last 6 months. Patients ever having taken or currently taking an erythropoietin medication. Iron deficiency (add criteria). On dialysis. Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years. Liver cirrhosis (add criteria).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Pavlik, CRA
Phone
310-474-9809
Email
spavlik@ptlcentral.com
Facility Information:
Facility Name
Targeted Medical Pharma
City
Los Angeles
State/Province
California
ZIP/Postal Code
90077
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Pavlik, CRA
Phone
310-474-9809
Email
spavlik@ptlcentral.com

12. IPD Sharing Statement

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An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease

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