Status:
UNKNOWN
An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease
Lead Sponsor:
Targeted Medical Pharma
Conditions:
Anemia of Chronic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01846689
Start Date
June 1 2013
End Date
September 1 2013
Last Update
May 3 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Targeted Medical Pharma
Los Angeles, California, United States, 90077