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

April 30, 2013 updated by: Targeted Medical Pharma

An Open-label Trial of an Erythropoietin Stimulating System to Determine Increased Red Blood Cell Production in Subjects Diagnosed With Anemia of Chronic Disease

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90077
        • Targeted Medical Pharma
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ESS
Prescription medical food erythropoietin stimulating system
Drug: ESS (medical food/drug)
Prescription medical food erythropoietin stimulating system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglogin/Hematocrit
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Red blood cell count
Time Frame: 28 Days
28 Days
Reticulocyte count
Time Frame: 28 days
28 days
IGF-1
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Targeted Medical Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E130426

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia of Chronic Disease

Clinical Trials on ESS (medical food/drug)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe