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

Targeted Medical Pharma

Status and phase: Unknown; Phase 3

Conditions: Anemia of Chronic Disease

Treatments: Drug: ESS (medical food/drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01846689

E130426

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ESS

Experimental group

Description:

Prescription medical food erythropoietin stimulating system

Treatment:

Drug: ESS (medical food/drug)