An Open-label Trial to Determine Increased Red Blood Cell... | NCT01846689

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

NCT01846689

Sponsor

Targeted Medical Pharma

Status

Unknown status

Last Update Posted

May 3, 2013Estimated

Enrollment

30Estimated

Phase

Phase 3

Conditions

Anemia of Chronic Disease

Interventions

ESS (medical food/drug)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Aug 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Apr 30, 2013

First Submission Date that Met QC Criteria

Apr 30, 2013

First Posted Date

May 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2013

Last Update Posted Date

May 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESS	Experimental	Prescription medical food erythropoietin stimulating system	Drug: ESS (medical food/drug)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ESS (medical food/drug)	Drug	Prescription medical food erythropoietin stimulating system	ESS

Measure	Description	Time Frame
Hemoglogin/Hematocrit		28 Days

Measure	Description	Time Frame
Red blood cell count		28 Days
Reticulocyte count		28 days
IGF-1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephanie Pavlik, CRA	Contact	310-474-9809		spavlik@ptlcentral.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Targeted Medical Pharma		Los Angeles	California	90077	United States