AnemiaPhase 3NCT00255424
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
A Phase 3 study testing ferumoxytol or oral iron in people with Anemia, run by AMAG Pharmaceuticals, Inc. at 19 sites in United States.
Trial summary
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- ferumoxytol or oral iron
- Type of treatment
- Pill or oral medicine
- How many people
- 304 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2004to Aug 2006
- 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
- Male or female patients ≥ 18 years.
- Have chronic kidney disease per K/DOQI guidelines.
- No change in EPO status during study.
- Baseline hemoglobin of ≤ 11.0 g/dl.
Who cannot join
- Women who are pregnant or lactating.
- Received another investigational drug or device within 30 days.
- Recent parenteral or oral iron therapy.
- Patients with active GI bleeding or acute bleeding within 4 weeks.
- Patients that have other causes of anemia.
- Major surgery within 30 days or anticipated or planned major surgery during the study.
Show all 10Show fewer
- Patients whose EPO status changes while on study.
- Patients with active infections.
- Recent blood transfusions.
- Patients with any known allergies to iron products.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Appleton, Wisconsin, 54911
Study site
Bluefield, West Virginia, 24701
Study site
Chattanooga, Tennessee, 37404
Study site
Columbus, Ohio, 43210
Study site
Detroit, Michigan, 48236
Study site
Encino, California, 91356
Study site
Fairfax, Virginia, 22030
Study site
Flushing, New York, 11355
Study site
Hershey, Pennsylvania, 17033
Study site
Houston, Texas, 77074
Study site
Knoxville, Tennessee, 37923
Study site
Lancaster, Pennsylvania, 17604
Study site
Ocala, Florida, 34471
Study site
Orchard Park, New York, 14127
Study site
Riverside, California, 92501
Study site
Shreveport, Louisiana, 71101
Study site
Shreveport, Louisiana, 71103
Study site
Springfield, Massachusetts, 01107
Study site
Tarzana, California, 91356
About this study
Official title: A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.
Read the detailed description
This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.
- Conditions
- Anemia
- Being tested
- ferumoxytol or oral iron
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferumoxytol or oral ironDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in hemoglobin from baseline.
Secondary outcomes (1)
Change in iron indices.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startMay 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 participants
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255424
- Sponsor's protocol ID
- 62745-6
- Status last verified
- Oct 2008
- First submitted
- 17 Nov 2005
- Last updated
- 9 Jan 2015
- Results posted
- No
Publications
Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
PubMed 16088081Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.
PubMed 18525001Fishbane S, Bolton WK, Winkelmayer WC, Strauss W, Li Z, Pereira BJ. Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Clin Nephrol. 2012 Sep;78(3):181-8. doi: 10.5414/cn107397.
PubMed 22874106
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis
- ClinicalTrials.gov ID
- NCT00255424
- Acronym / sponsor ID
- 62745-6
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants
- Lead sponsor
- AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 21 Nov 2005 (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 study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.
Detailed description
This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients ≥ 18 years.
- Have chronic kidney disease per K/DOQI guidelines.
- No change in EPO status during study.
- Baseline hemoglobin of ≤ 11.0 g/dl.
Key exclusion criteria (10 listed)
- Women who are pregnant or lactating.
- Received another investigational drug or device within 30 days.
- Recent parenteral or oral iron therapy.
- Patients with active GI bleeding or acute bleeding within 4 weeks.
- Patients that have other causes of anemia.
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 |
|---|---|---|
| ferumoxytol or oral iron | Drug | – |
Primary outcome
The mean change in hemoglobin from baseline.
1 secondary outcome
Change in iron indices.
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 9 Jan 2015.
- Background: PubMed 16088081Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
- Results publication: PubMed 18525001Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.
- Results publication: PubMed 22874106Fishbane S, Bolton WK, Winkelmayer WC, Strauss W, Li Z, Pereira BJ. Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Clin Nephrol. 2012 Sep;78(3):181-8. doi: 10.5414/cn107397.
- National Kidney FoundationLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ferumoxytol or oral iron in people with Anemia, run by AMAG Pharmaceuticals, Inc. at 19 sites 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 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: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
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?
The mean change in hemoglobin from baseline.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00255424, which also lists 3 linked publications.
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 9 Jan 2015.