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

• Sponsor: Targeted Medical Pharma (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01846689
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 9.9

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• 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
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESS Prescription medical food erythropoietin stimulating system	Drug: ESS (medical food/drug); Prescription medical food erythropoietin stimulating system

Outcome Measures

Primary Outcome Measures

1. Hemoglogin/Hematocrit [28 Days]

Secondary Outcome Measures

1. Red blood cell count [28 Days]

2. Reticulocyte count [28 days]

3. IGF-1 [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Targeted Medical Pharma	Los Angeles	California	United States	90077

Sponsors and Collaborators

• Targeted Medical Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Targeted Medical Pharma
• ClinicalTrials.gov Identifier: NCT01846689
• Other Study ID Numbers: E130426
• First Posted: May 3, 2013
• Last Update Posted: May 3, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Anemia; Polycythemia; Chronic Disease

Study Results

No Results Posted as of May 3, 2013