Iron Deficiency AnemiaPhase 4NCT01148745
Iron Indices and Intravenous Ferumoxytol: Time to Steady State
A Phase 4 study testing ferumoxytol in people with Iron Deficiency Anemia, run by Dialysis Clinic, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- ferumoxytol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic hemodialysis subjects who have received dialysis treatment for more than 90 days
- TSAT less than or equal to 25 percent
- Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)
- (Female) Subjects are willing to use reliable contraception, or have undergone menopause (chemical or surgical)
- Subjects who are able to read and write in English
- Subjects who have signed consent
Who cannot join
- Subjects who have been enrolled in a clinical trial within the past 30 days
- Subjects who have received IV iron within 4 weeks of the start of the study
- Serum ferritin greater than or equal to 1200 ng/dL
- Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL
- Evidence of iron overload
- Known hypersensitivity to ferumoxytol or any of its components
Show all 18Show fewer
- Anemia caused by conditions other than iron deficiency
- Subjects with elective surgeries scheduled within the next 3 months
- Subjects with elective magnetic resonance procedure scheduled during the study period
- Subjects who have been hospitalized within the past 30 days (excluding vascular access care)
- Subjects who have received a blood transfusion in the past 30 days
- Subjects who are transfusion dependent
- (Female) Subjects who are pregnant or nursing
- Subjects with known inflammatory conditions which may affect serum ferritin
- Subjects who are considered to be clinically unstable at the discretion of Principal Investigator (P.I.)
- Subjects who have a clinically unstable blood pressure (BP) of systolic greater than 180 millimeters of mercury (mmHg) and/or diastolic greater than 100 mmHg (sitting, pre-dialysis)
- Subjects with life expectancy less than 6 months
- Subjects who refuse to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Dialysis Clinic, Inc.
North Brunswick, New Jersey, 08902
About this study
The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.
- Conditions
- Iron Deficiency Anemia
- Being tested
- ferumoxytol
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferumoxytolDrug
Also called Feraheme
510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection)
| Study group | Role | What they receive |
|---|---|---|
| ferumoxytol | Other | FDA approved drug Receives: Drug: ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize
TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.
Measured: pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration
Secondary outcomes (2)
Transferrin Saturation (TSAT)
Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100
Measured: 7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.
Serum Ferritin
Serum ferritin values were measured at all visits
Measured: 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iron Deficiency AnemiaStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dialysis Clinic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toros Kapoian, MD, Principal investigator, DCI North Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148745
- Sponsor's protocol ID
- DCI-0001
- Status last verified
- Mar 2012
- First submitted
- 21 Jun 2010
- Last updated
- 30 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Indices and Intravenous Ferumoxytol: Time to Steady State
- ClinicalTrials.gov ID
- NCT01148745
- Acronym / sponsor ID
- DCI-0001
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dialysis Clinic, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 30 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ferumoxytol | Other | Drug: ferumoxytolFDA approved drug |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic hemodialysis subjects who have received dialysis treatment for more than 90 days
- TSAT less than or equal to 25 percent
- Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)
- (Female) Subjects are willing to use reliable contraception, or have undergone menopause (chemical or surgical)
- Subjects who are able to read and write in English
Key exclusion criteria (18 listed)
- Subjects who have been enrolled in a clinical trial within the past 30 days
- Subjects who have received IV iron within 4 weeks of the start of the study
- Serum ferritin greater than or equal to 1200 ng/dL
- Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL
- Evidence of iron overload
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 |
|---|---|---|
| ferumoxytolAlso: Feraheme510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection) | Drug | ferumoxytol |
Primary outcome
Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize
Time frame: pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration
TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.
2 secondary outcomes
Transferrin Saturation (TSAT)
Time frame: 7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.
Serum Ferritin
Time frame: 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Toros Kapoian, MD principal investigator
DCI North Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ferumoxytol in people with Iron Deficiency Anemia, run by Dialysis Clinic, Inc. 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 6 inclusion and 18 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 30 Mar 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize (time frame: pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration). 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 30 Mar 2012.