Anemia of Chronic Disease
Conditions
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.
Interventions
DRUGESS (medical food/drug)
Prescription medical food erythropoietin stimulating system
Sponsors
Targeted Medical Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglogin/Hematocrit | 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| Red blood cell count | 28 Days |
| Reticulocyte count | 28 days |
| IGF-1 | 28 days |
Countries
United States
Contacts
Primary ContactStephanie Pavlik, CRA
Outcome results
None listed