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

Status unconfirmed · Phase 3

Conditions studied: Anemia of Chronic Disease

In brief

The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.

Key facts

Study ID

NCT01846689

Run by

Targeted Medical Pharma

People needed

30

Starts

2013-06-01

Expected to finish

2013-09-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Targeted Medical Pharma — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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