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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- M/F patients 18 years old and over, non-pregnant/lactating
- Hemoglobin < 10 female,<11 male
- Ferritin > upper limit of normal for lab indicative of chronic anemia
- Anemia of chronic disease
- Crt. < 3.0
Exclusion Criteria
- Currently taking other amino acid formulations.
- Pregnant or unwilling to use adequate birth control for the duration of the study.
- Excessive alcohol or illicit drug use.
- Unwilling or unable to sign informed consent.
- Myocardial infarction within the last 6 months.
- Patients ever having taken or currently taking an erythropoietin medication.
- Iron deficiency (add criteria).
- On dialysis.
- 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.
- 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