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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Targeted Medical Pharma.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01846689
First Posted: May 3, 2013
Last Update Posted: May 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Targeted Medical Pharma
  Purpose
The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.

Condition Intervention Phase
Anemia of Chronic Disease Drug: ESS (medical food/drug) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Targeted Medical Pharma:

Primary Outcome Measures:
  • Hemoglogin/Hematocrit [ Time Frame: 28 Days ]

Secondary Outcome Measures:
  • Red blood cell count [ Time Frame: 28 Days ]
  • Reticulocyte count [ Time Frame: 28 days ]
  • IGF-1 [ Time Frame: 28 days ]

Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESS
Prescription medical food erythropoietin stimulating system
Drug: ESS (medical food/drug)
Prescription medical food erythropoietin stimulating system

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846689


Contacts
Contact: Stephanie Pavlik, CRA 310-474-9809 spavlik@ptlcentral.com

Locations
United States, California
Targeted Medical Pharma Not yet recruiting
Los Angeles, California, United States, 90077
Contact: Stephanie Pavlik, CRA    310-474-9809    spavlik@ptlcentral.com   
Sponsors and Collaborators
Targeted Medical Pharma
  More Information

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01846689     History of Changes
Other Study ID Numbers: E130426
First Submitted: April 30, 2013
First Posted: May 3, 2013
Last Update Posted: May 3, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Anemia
Chronic Disease
Hematologic Diseases
Disease Attributes
Pathologic Processes
Epoetin Alfa
Hematinics