AnemiaPhase 3NCT00396292

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

A Phase 3 study testing Oral iron tablets and VIT-45 in people with Anemia, run by American Regent, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Anemia
What is being tested?: Oral iron tablets and VIT-45
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 361 participants
Where: 1 siteUnited States
Study dates: Feb 2005to Feb 2006
Phase: Phase 3
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
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Female Subjects able to give consent
Post partum patients
Baseline Hbg< /= 10
Agree to practice birth control
Demonstrate willingness to comply with protocol restrictions

Who cannot join

Known hypersensitivity reaction to oral or IV iron (VIT-45)
Documented history of discontinuing oral iron
Significant bleeding
History of anemia other that iron deficiency anemia
Severe Psychiatric disorders
Active severe infection

Show all 11Show fewer

Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
Known HIV antibody
Received investigational product within 30 days
Alcohol abuse
Hemochromatosis or other iron storage disorder

Trial locations and contacts

1 site in 1 country.

United States1 site

Luitpold Pharmaceuticals
Norristown, Pennsylvania, 19403

Other trials in United States

About this study

Official title: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Read the detailed description

This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Conditions: Anemia
Being tested: Oral iron tablets, VIT-45
Keywords: Anemia, postpartum, Postpartum anemia
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral iron tabletsDrug
Also called Ferrous Sulfate
325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
VIT-45Drug
A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

Study groups in NCT00396292
Study group	Role	What they receive
VIT-45	Experimental	A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered Receives: Drug: VIT-45
Oral iron tablets	Active comparator	325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42 Receives: Drug: Oral iron tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin
Measured: anytime between baseline and the end of study or time to intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Feb 2006

First posted6 Nov 2006 (estimated)
Study startFeb 2005
Primary completionNov 2005
Study completionFeb 2006

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.
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: Parallel groups
Masking: None (open label)
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00396292
Sponsor's protocol ID: 1VIT03001
Status last verified: Jan 2018
First submitted: 2 Nov 2006
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Baker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
Baker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.
PubMed 17666600

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia
ClinicalTrials.gov ID: NCT00396292
Acronym / sponsor ID: 1VIT03001
Conditions: Anemia
Keywords: Anemia, postpartum, Postpartum anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: Nov 2005 (actual)
Study completion: Feb 2006 (actual)
First posted: 6 Nov 2006 (estimated)
Results: Posted 10 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Detailed description

This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VIT-45	Experimental	Drug: VIT-45A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
Oral iron tablets	Active comparator	Drug: Oral iron tablets325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Female Subjects able to give consent
Post partum patients
Baseline Hbg< /= 10
Agree to practice birth control
Demonstrate willingness to comply with protocol restrictions

Key exclusion criteria (11 listed)

Known hypersensitivity reaction to oral or IV iron (VIT-45)
Documented history of discontinuing oral iron
Significant bleeding
History of anemia other that iron deficiency anemia
Severe Psychiatric disorders

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
Oral iron tabletsAlso: Ferrous Sulfate325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42	Drug	Oral iron tablets
VIT-45A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered	Drug	VIT-45

Primary outcome

Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin
Time frame: anytime between baseline and the end of study or time to intervention

Results and safety

Results posted to the registry on 10 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VIT-45	174	165
Oral Iron Tablets	178	162

Primary outcome: Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin

Time frame: anytime between baseline and the end of study or time to intervention. Number. Unit: participants

Measure	VIT-45 n = 168	Oral Iron Tablets n = 169
Value	162	159

Population analysed: Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being \<11.0 g/dL

Adverse events

Time frame: 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VIT-45	4 of 174 (2.3%)	40 of 174 (23%)	Not reported
Oral Iron Tablets	4 of 178 (2.2%)	61 of 178 (34.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationBaker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
Results publicationBaker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
Derived from this study: PubMed 17666600Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.

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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.

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 Oral iron tablets and VIT-45 in people with Anemia, run by American Regent, 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 5 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 5 Feb 2018. 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?

Yes. Results are posted in the registry (first posted 10 Dec 2013). 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 Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin (time frame: anytime between baseline and the end of study or time to intervention). 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 NCT00396292, 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 5 Feb 2018.