Anemia of Chronic DiseasePhase 3NCT01846689
An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease
A Phase 3 study testing ESS (medical food/drug) in people with Anemia of Chronic Disease, run by Targeted Medical Pharma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Disease
- What is being tested?
- ESS (medical food/drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Targeted Medical Pharma
Los Angeles, California, 90077
Stephanie Pavlik, CRA, 310-474-9809, spavlik@ptlcentral.com
About this study
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
The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.
- Conditions
- Anemia of Chronic Disease
- Being tested
- ESS (medical food/drug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESS (medical food/drug)Drug
Prescription medical food erythropoietin stimulating system
| Study group | Role | What they receive |
|---|---|---|
| ESS | Experimental | Prescription medical food erythropoietin stimulating system Receives: Drug: ESS (medical food/drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglogin/Hematocrit
Measured: 28 Days
Secondary outcomes (3)
Red blood cell count
Measured: 28 Days
Reticulocyte count
Measured: 28 days
IGF-1
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Targeted Medical Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846689
- Sponsor's protocol ID
- E130426
- Status last verified
- Apr 2013
- First submitted
- 30 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01846689
- Acronym / sponsor ID
- E130426
- Conditions
- Anemia of Chronic Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Targeted Medical PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESS | Experimental | Drug: ESS (medical food/drug)Prescription medical food erythropoietin stimulating system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESS (medical food/drug)Prescription medical food erythropoietin stimulating system | Drug | ESS |
Primary outcome
Hemoglogin/Hematocrit
Time frame: 28 Days
3 secondary outcomes
Red blood cell count
Time frame: 28 Days
Reticulocyte count
Time frame: 28 days
IGF-1
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ESS (medical food/drug) in people with Anemia of Chronic Disease, run by Targeted Medical Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Pavlik, CRA (310-474-9809, spavlik@ptlcentral.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglogin/Hematocrit (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.