Trial record 2 of 199 for:    Open Studies | "Chronic Disease"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Targeted Medical Pharma
Sponsor:
Information provided by (Responsible Party):
Targeted Medical Pharma
ClinicalTrials.gov Identifier:
NCT01846689
First received: April 30, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Red blood cell count [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Reticulocyte count [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • IGF-1 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01846689     History of Changes
Other Study ID Numbers: E130426
Study First Received: April 30, 2013
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Chronic Disease
Disease Attributes
Hematologic Diseases
Pathologic Processes
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014