Anemia, Iron DeficiencyNCT03310736
Serum Hepcidin Immunoassay - Laboratory to Marketplace
An observational study of Anemia, Iron Deficiency, run by Intrinsic LifeSciences, LLC at 1 site in United States.
Trial summary
This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron deficiency (ID) in adolescents and young adults. This test is considered non-significant risk. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- Intrinsic Hepcidin IDx™ Test
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 28 Feb 2019
- Phase
- Observational
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The primary care clinic at Boston Children's Hospital (BCH) Adolescent/Young Adult (AYA) Clinic, BCH Sports Medicine Clinic, or at Boston Children's Physicians Weymouth
Who may be able to join
- Age at least 11 years
- Subjects must give informed assent/ consent prior to the blood draw. Subjects that are minors (<18 years) must have a parent or guardian give informed consent and the subject must give assent to participate in the study.
- Willing to comply with all oral iron supplementation and follow up visits if they move to the Observation of Treatment Phase.
- Able to communicate in English.
Who cannot join
- Acute febrile illness (Temp ≥100.4°F (38°C), or acute otitis media, gastroenteritis, pharyngitis or other URI, within the previous one week.
- History of known hemoglobinopathy (e.g., thalassemia trait or sickle cell)
- Any parenteral iron received in the 30 days prior to enrollment.
- Presently taking oral iron supplements (except for iron as part of multivitamin or oral contraceptive pill) or has taken it in the 30 days prior to enrollment.
- An allergy or hypersensitivity to oral iron sulfate.
- Has received a blood transfusion in the 90 days prior to enrollment.
Show all 11Show fewer
- Any investigational drug use in the 30 days prior to enrollment.
- Any known malignancy.
- Receiving dialysis.
- Known to be pregnant or currently breast-feeding.
- Any lab abnormality, medical condition, or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Evaluation of the Intrinsic Hepcidin IDx™ Test to Detect Iron Deficiency and Predict Response to Oral Iron Therapy in Adolescents and Young Adults
This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron deficiency (ID) in adolescents and young adults. This test is considered non-significant risk.
Read the detailed description
This observational study is composed of two phases, and no investigational intervention agent. Oral iron therapy will be recommended by each subject's primary care clinician or his/her designate according to standard clinical care. There is no randomization. Subjects will be screened for enrollment by study personnel.
Diagnostic Testing Phase (Study Visit 1). Enrolled subjects will have a study blood draw. Enrolled subjects will be assessed for presence of ID as defined by the reference standard: ID: Ferritin < 20 ng/mL.
Enrolled subjects will be assessed for presence of anemia as defined by: Anemia - Hemoglobin ≤ 11 g/dL
Those determined to have ID and/or anemia and are prescribed oral iron therapy by their clinician will continue to the next phase in the study. For those without ID or anemia, or who meet Observation of Treatment Phase exclusion criteria, study participation will be complete. The expected duration of subject involvement for the Diagnostic Testing Phase is 1 week.
Observation of Treatment Phase (Study Visits 2 and 3). Subjects identified as having ID and/or anemia and who have been prescribed oral iron therapy by their physician according to standard of care, and do not meet Observation of Treatment Phase exclusion criteria, will continue to the Observation of Treatment Phase of the study.
The optimal dose, frequency, and timing of oral iron therapy are unknown and are based more on clinical experience than evidence. In 1998, based on expert opinion, the Centers for Disease Control (CDC) suggested 3 mg/kg/day of elemental iron for treatment of IDA in children. Patients with ID who do not have anemia (LID) should also have their iron stores repleted with treatment dose iron supplement. Given the effects of acute/chronic disease on serum ferritin and the dietary/diurnal variation of serum iron/TfSat, the absence of biochemical evidence of ID on a single measure does not rule out ID that may respond to empiric supplementation. Therefore, patients with anemia but without biochemical evidence of ID (AneID) may have masked ID and treatment with a finite course of supplemental iron therapy is unlikely to result in harm and may improve hemoglobin. Thus, we expect all subjects with ID and/or anemia will be recommended treatment by their clinician with ferrous sulfate at treatment at standard doses for adolescents and young adults of 3-5 mg elemental iron/kg/day, up to a maximum of 195 mg of elemental iron per day.
Investigators will provide responsible clinicians with recommendations for ferrous sulfate treatment along with references to relevant clinical guidelines and research. The clinicians will be asked to provide the research team confirmation that the patient followed the oral iron treatment recommendations. If they did not, they will be asked to indicate what treatment, if any, they did advise for the subject.
Subjects who continue to the Observation of Treatment Phase will have two follow-up visits and laboratory testing, including a study draw for hepcidin at each visit, to assess response to oral iron supplementation at:
- 4-5 weeks (+/- 7 days) of therapy, and
- 12 weeks (+/- 7 days) of therapy.
- Conditions
- Anemia, Iron Deficiency
- Being tested
- Intrinsic Hepcidin IDx™ Test
- Keywords
- iron deficiency, anemia, hepcidin
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic Hepcidin IDx™ TestDiagnostic test
ILS scientists developed the bioanalytical method for quantitation of human serum hepcidin using a Beckman FX automated liquid handling platform. The method uses a competitive ELISA format that has a proprietary sensitive and specific monoclonal antibody to hepcidin that captures native hepcidin in a sample. During the reaction a competition between a synthetic, bioactive, biotinylated hepcidin tracer and native hepcidin occurs. Bound biotinylated tracer is detected with a streptavidin-HRP conjugate and TMB substrate. Quantitation is based on an eight-point standard curve using validated, synthetic hepcidin calibrators. The standard curve and the hepcidin concentrations of patients samples are calculated using 4-parameter logistic curve fitting (Prism; Graphpad, Inc., La Jolla, CA). Serum hepcidin concentrations are expressed in ng/ml serum.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the Intrinsic Hepcidin IDx test
To demonstrate the diagnostic accuracy of the Intrinsic Hepcidin IDx TestTM to diagnose ID in adolescents and young adults, where diagnostic accuracy is defined by the lower 95% confidence interval on sensitivity (Se) being not less than 70% and the lower 95% confidence interval on specificity (Sp) not being less than 70%.
Measured: 12 weeks
Secondary outcomes (2)
Prediction of Response to Oral Iron Therapy
To evaluate the ability of the Intrinsic Hepcidin IDx TestTM to predict a response to oral iron therapy in adolescents and young adults with ID
Measured: 12 weeks
Predict Therapeutic Response to Oral Iron Therapy
To evaluate the ability of the Intrinsic Hepcidin IDx TestTM to predict a therapeutic response to oral iron therapy in adolescents and young adults with anemia and no biochemical evidence of iron deficiency
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start30 Jun 2016
- Primary completion31 Dec 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intrinsic LifeSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Matthew M Heeney, MD, Principal investigator, PhysicianLydia A Shrier, MD, MPH, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310736
- Sponsor's protocol ID
- ILS-0001
- Status last verified
- Jun 2019
- First submitted
- 10 Oct 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intrinsic Hepcidin IDx™ Test to Detect Iron Deficiency and Predict Response to Oral Iron Therapy in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT03310736
- Acronym / sponsor ID
- ILS-0001
- Conditions
- Anemia, Iron Deficiency
- Keywords
- iron deficiency, anemia, hepcidin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Intrinsic LifeSciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 16 Oct 2017 (actual)
- 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.
This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron deficiency (ID) in adolescents and young adults. This test is considered non-significant risk.
Detailed description
This observational study is composed of two phases, and no investigational intervention agent. Oral iron therapy will be recommended by each subject's primary care clinician or his/her designate according to standard clinical care. There is no randomization. Subjects will be screened for enrollment by study personnel.
Diagnostic Testing Phase (Study Visit 1). Enrolled subjects will have a study blood draw. Enrolled subjects will be assessed for presence of ID as defined by the reference standard: ID: Ferritin < 20 ng/mL.
Enrolled subjects will be assessed for presence of anemia as defined by: Anemia - Hemoglobin ≤ 11 g/dL
Those determined to have ID and/or anemia and are prescribed oral iron therapy by their clinician will continue to the next phase in the study. For those without ID or anemia, or who meet Observation of Treatment Phase exclusion criteria, study participation will be complete. The expected duration of subject involvement for the Diagnostic Testing Phase is 1 week.
Observation of Treatment Phase (Study Visits 2 and 3). Subjects identified as having ID and/or anemia and who have been prescribed oral iron therapy by their physician according to standard of care, and do not meet Observation of Treatment Phase exclusion criteria, will continue to the Observation of Treatment Phase of the study.
The optimal dose, frequency, and timing of oral iron therapy are unknown and are based more on clinical experience than evidence. In 1998, based on expert opinion, the Centers for Disease Control (CDC) suggested 3 mg/kg/day of elemental iron for treatment of IDA in children. Patients with ID who do not have anemia (LID) should also have their iron stores repleted with treatment dose iron supplement. Given the effects of acute/chronic disease on serum ferritin and the dietary/diurnal variation of serum iron/TfSat, the absence of biochemical evidence of ID on a single measure does not rule out ID that may respond to empiric supplementation. Therefore, patients with anemia but without biochemical evidence of ID (AneID) may have masked ID and treatment with a finite course of supplemental iron therapy is unlikely to result in harm and may improve hemoglobin. Thus, we expect all subjects with ID and/or anemia will be recommended treatment by their clinician with ferrous sulfate at treatment at standard doses for adolescents and young adults of 3-5 mg elemental iron/kg/day, up to a maximum of 195 mg of elemental iron per day.
Investigators will provide responsible clinicians with recommendations for ferrous sulfate treatment along with references to relevant clinical guidelines and research. The clinicians will be asked to provide the research team confirmation that the patient followed the oral iron treatment recommendations. If they did not, they will be asked to indicate what treatment, if any, they did advise for the subject.
Subjects who continue to the Observation of Treatment Phase will have two follow-up visits and laboratory testing, including a study draw for hepcidin at each visit, to assess response to oral iron supplementation at:
- 4-5 weeks (+/- 7 days) of therapy, and
- 12 weeks (+/- 7 days) of therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The primary care clinic at Boston Children's Hospital (BCH) Adolescent/Young Adult (AYA) Clinic, BCH Sports Medicine Clinic, or at Boston Children's Physicians Weymouth
Key inclusion criteria (4 listed)
- Age at least 11 years
- Subjects must give informed assent/ consent prior to the blood draw. Subjects that are minors (<18 years) must have a parent or guardian give informed consent and the subject must give assent to participate in the study.
- Willing to comply with all oral iron supplementation and follow up visits if they move to the Observation of Treatment Phase.
- Able to communicate in English.
Key exclusion criteria (11 listed)
- Acute febrile illness (Temp ≥100.4°F (38°C), or acute otitis media, gastroenteritis, pharyngitis or other URI, within the previous one week.
- History of known hemoglobinopathy (e.g., thalassemia trait or sickle cell)
- Any parenteral iron received in the 30 days prior to enrollment.
- Presently taking oral iron supplements (except for iron as part of multivitamin or oral contraceptive pill) or has taken it in the 30 days prior to enrollment.
- An allergy or hypersensitivity to oral iron sulfate.
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 |
|---|---|---|
| Intrinsic Hepcidin IDx™ TestILS scientists developed the bioanalytical method for quantitation of human serum hepcidin using a Beckman FX automated liquid handling platform. The method uses a competitive ELISA format that has a proprietary sensitive and specific monoclonal antibody to hepcidin that captures native hepcidin in a sample. During the reaction a competition between a synthetic, bioactive, biotinylated hepcidin tracer and native hepcidin occurs. Bound biotinylated tracer is detected with a streptavidin-HRP conjugate and TMB substrate. Quantitation is based on an eight-point standard curve using validated, synthetic hepcidin calibrators. The standard curve and the hepcidin concentrations of patients samples are calculated using 4-parameter logistic curve fitting (Prism; Graphpad, Inc., La Jolla, CA). Serum hepcidin concentrations are expressed in ng/ml serum. | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of the Intrinsic Hepcidin IDx test
Time frame: 12 weeks
To demonstrate the diagnostic accuracy of the Intrinsic Hepcidin IDx TestTM to diagnose ID in adolescents and young adults, where diagnostic accuracy is defined by the lower 95% confidence interval on sensitivity (Se) being not less than 70% and the lower 95% confidence interval on specificity (Sp) not being less than 70%.
2 secondary outcomes
Prediction of Response to Oral Iron Therapy
Time frame: 12 weeks
Predict Therapeutic Response to Oral Iron Therapy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Matthew M Heeney, MD principal investigator
Physician
Lydia A Shrier, MD, MPH principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Iron Deficiency, run by Intrinsic LifeSciences, LLC 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 18 Jun 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the Intrinsic Hepcidin IDx test (time frame: 12 weeks). 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 18 Jun 2019.