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

Phase 3

• Conditions: Anemia of Chronic Disease
• Interventions: Drug: ESS (medical food/drug)

• Registration Number: NCT01846689
• Lead Sponsor: Targeted Medical Pharma

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-04-30
• Last Update Submitted: 2013-04-30
• Study First Posted: 2013-05-03
• Last Update Posted: 2013-05-03
• Study Start: 2013-06
• Primary Completion: 2013-08
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESS	ESS (medical food/drug)	Prescription medical food erythropoietin stimulating system

Primary Outcome Measures

Name	Time	Method
Hemoglogin/Hematocrit	28 Days

Secondary Outcome Measures

Name	Time	Method
Red blood cell count	28 Days
Reticulocyte count	28 days
IGF-1	28 days

Trial Locations

Locations (1)

Targeted Medical Pharma; 🇺🇸 Los Angeles, California, United States