NCT01846689

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

April 30, 2013

Last Update Submit

April 30, 2013

Conditions

Anemia of Chronic Disease

Outcome Measures

Primary Outcomes (1)

  • Hemoglogin/Hematocrit

    28 Days

Secondary Outcomes (3)

  • Red blood cell count

    28 Days

  • Reticulocyte count

    28 days

  • IGF-1

    28 days

Study Arms (1)

ESS

EXPERIMENTAL

Prescription medical food erythropoietin stimulating system

Drug: ESS (medical food/drug)

Interventions

ESS (medical food/drug)DRUG

Prescription medical food erythropoietin stimulating system

ESS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Targeted Medical Pharma

Los Angeles, California, 90077, United States

Location

Central Study Contacts

Stephanie Pavlik, CRA

CONTACT

310-474-9809spavlik@ptlcentral.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

US(1)