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

Anemia of Chronic Disease Clinical Trial

Official title:

An Open-label Trial of an Erythropoietin Stimulating System to Determine Increased Red Blood Cell Production in Subjects Diagnosed With Anemia of Chronic Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01846689
• Other study ID #: E130426
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 30, 2013
• Last updated: April 30, 2013
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: April 2013
• Source: Targeted Medical Pharma
• Contact: Stephanie Pavlik, CRA
• Phone: 310-474-9809
• Email: spavlik[@]ptlcentral.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Disease
• Chronic Disease

Intervention

Drug:
• ESS (medical food/drug)
Prescription medical food erythropoietin stimulating system

Locations

Country	Name	City	State
United States	Targeted Medical Pharma	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Targeted Medical Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglogin/Hematocrit		28 Days	No
Secondary	Red blood cell count		28 Days	No
Secondary	Reticulocyte count		28 days	No
Secondary	IGF-1		28 days	No