AnemiaPhase 3NCT00317239

VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

A Phase 3 study testing Ferrous Sulfate tablets and Ferric Carboxymaltose (FCM) 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 efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD). Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Anemia
What is being tested?: Ferrous Sulfate tablets and Ferric Carboxymaltose (FCM)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 1 siteUnited States
Study dates: May 2005to Aug 2007
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Males or females > or = 12 years of age
NDD-CKD subjects
Baseline hemoglobin < or = 11g/dl
Stable erythropoietin (EPO) status

Who cannot join

Known hypersensitivity to ferrous sulfate or IV iron
Unstable EPO status
Anemia not related to CKD
Chronic, serious infection
Recent IV iron
Recent blood transfusion

Show all 10Show fewer

Recent blood loss
Need for surgery
Received investigational drug within 30 days
Female subjects who are pregnant or lactating

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 Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Read the detailed description

Conditions: Anemia
Being tested: Ferrous Sulfate tablets, Ferric Carboxymaltose (FCM)
Keywords: Anemia, Chronic Kidney Disease, Iron
Medical subject headings: Anemia, Renal Insufficiency, Chronic

What participants receive

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

Ferrous Sulfate tabletsDrug
325 mg/TID x 8 weeks
Ferric Carboxymaltose (FCM)Drug
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.

Study groups in NCT00317239
Study group	Role	What they receive
Ferric Carboxymaltose (FCM)	Experimental	A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. Receives: Drug: Ferric Carboxymaltose (FCM)
Ferrous Sulfate tablets	Active comparator	325 mg/TID x 8 weeks Receives: Drug: Ferrous Sulfate tablets

What is being measured

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

Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
Measured: anytime during the study

Timeline

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

May 2005Aug 2007

First posted24 Apr 2006 (estimated)
Study startMay 2005
Primary completionFeb 2007
Study completionAug 2007

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 (2)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: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00317239
Sponsor's protocol ID: 1VIT04004
Status last verified: Jan 2018
First submitted: 20 Apr 2006
Last updated: 20 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant. 2011 May;26(5):1599-607. doi: 10.1093/ndt/gfq613. Epub 2010 Oct 7.
PubMed 20929915
Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.

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 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
ClinicalTrials.gov ID: NCT00317239
Acronym / sponsor ID: 1VIT04004
Conditions: Anemia
Keywords: Anemia, Chronic Kidney Disease, Iron
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 255 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Feb 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 24 Apr 2006 (estimated)
Results: Posted 25 Nov 2013

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Ferric Carboxymaltose (FCM)	Experimental	Drug: Ferric Carboxymaltose (FCM)A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
Ferrous Sulfate tablets	Active comparator	Drug: Ferrous Sulfate tablets325 mg/TID x 8 weeks

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Males or females > or = 12 years of age
NDD-CKD subjects
Baseline hemoglobin < or = 11g/dl
Stable erythropoietin (EPO) status

Key exclusion criteria (10 listed)

Known hypersensitivity to ferrous sulfate or IV iron
Unstable EPO status
Anemia not related to CKD
Chronic, serious infection
Recent IV iron

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
Ferrous Sulfate tablets325 mg/TID x 8 weeks	Drug	Ferrous Sulfate tablets
Ferric Carboxymaltose (FCM)A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.	Drug	Ferric Carboxymaltose (FCM)

Primary outcome

Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
Time frame: anytime during the study

Results and safety

Results posted to the registry on 25 Nov 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
Ferric Carboxymaltose (FCM)	147	134
Ferrous Sulfate Tablets	103	84

Primary outcome: Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL

Time frame: anytime during the study. Number. Unit: participants

Measure	Ferric Carboxymaltose (FCM) n = 144	Ferrous Sulfate Tablets n = 101
Value	87	35

Population analysed: Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73²

Adverse events

Time frame: 1 year and 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ferric Carboxymaltose (FCM)	13 of 147 (8.8%)	11 of 147 (7.5%)	Not reported
Ferrous Sulfate Tablets	10 of 103 (9.7%)	20 of 103 (19.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20929915Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant. 2011 May;26(5):1599-607. doi: 10.1093/ndt/gfq613. Epub 2010 Oct 7.
Results publicationQunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.

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Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
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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 Ferrous Sulfate tablets and Ferric Carboxymaltose (FCM) 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 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 20 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 25 Nov 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 Achieving an Increase in Hemoglobin ≥1g/dL (time frame: anytime during the study). 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 NCT00317239, which also lists 2 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 20 Feb 2018.