Iron Deficiency AnemiaPhase 2/3NCT00223977
2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
A Phase 2/3 study testing Sodium Ferric Gluconate Complex and Oral Iron in people with Iron Deficiency Anemia, run by Watson Pharmaceuticals at 43 sites in 8 countries.
Trial summary
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Sodium Ferric Gluconate Complex and Oral Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 43 sitesin 8 countries
- Study dates
- Dec 2003to Feb 2008
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age.
- Received maintenance peritoneal dialysis therapy for at least 4 weeks.
- Was expected to remain on peritoneal dialysis therapy for duration of study.
- Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
- Signed patient informed consent.
Who cannot join
- Had a predetermined serum levels of Ferritin and TSAT
- Pregnant or lactating.
- Had a serious concomitant medical disorder incompatible with participation in the study.
- Had a known hypersensitivity to Ferrlecit or any of its components.
- Unable to cooperate or comply with the protocol.
Trial locations and contacts
43 sites in 8 countries.
43 sites in 8 countries
United States19 sites
Study site
Birmingham, Alabama
Study site
Chapel Hill, North Carolina
Study site
Dallas, Texas
Study site
Evanston, Illinois
Study site
Los Angeles, California
Study site
Mesa, Arizona
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
Richmond, Virginia
Study site
Royal Oak, Michigan
Study site
Shreveport, Louisiana
Study site
Sioux Falls, South Dakota
Study site
Springfield, Massachusetts
Study site
St Louis, Missouri
Study site
Torrance, California
Study site
Tulsa, Oklahoma
Study site
Winston-Salem, North Carolina
Study site
Worcester, Massachusetts
India7 sites
Study site
Bangalore
Study site
Chandigarh
Study site
Chennai
Study site
Hyderabad
Study site
Lucknow
Study site
Mahīm
Study site
New Delhi
Mexico6 sites
Study site
Col. Toriello Guerra
Study site
Durango
Study site
Mexico City
Study site
Monterrey
Study site
Tlalpan
Study site
Zapopan
Canada5 sites
Study site
Kelowna
Study site
Kitchener
Study site
London
Study site
Scarborough
Study site
Toronto
About this study
Official title: A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Sodium Ferric Gluconate Complex, Oral Iron
- Keywords
- Anemia.
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Ferric Gluconate ComplexDrug
Also called Ferrlecit
125 mg weekly x 8 weeks
Sodium Ferric Gluconate ComplexDrug
Also called Ferrlecit
250 mg weekly x 4
Oral IronDrug
325 mg ferrous sulfate orally three times daily x 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sodium ferric gluconate complex 125 mg | Experimental | 125 mg sodium ferric gluconate weekly x 8 weeks Receives: Drug: Sodium Ferric Gluconate Complex |
| Sodium ferric gluconate complex 250 mg | Experimental | 250 mg sodium ferric gluconate complex weekly x 4 weeks Receives: Drug: Sodium Ferric Gluconate Complex |
| Oral iron | Active comparator | 325 mg ferrous sulfate three times daily x 8 weeks Receives: Drug: Oral Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Measured: Baseline to 5 weeks and 9 weeks
Secondary outcomes (4)
Change From Baseline in Hematocrit (Hct)
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Measured: Baseline to 5 weeks and 9 weeks
Change From Baseline in Transferrin Saturation (TSAT).
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Measured: Baseline to 5 weeks and 9 weeks
Change From Baseline in Serum Ferritin.
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Measured: Baseline to 5 weeks and 9 weeks
Responders by Treatment Group
Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.
Measured: Baseline to 5 weeks and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionNov 2004
- Study completionFeb 2008
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Hoel, RPh, PhD, Study chair, Watson Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223977
- Sponsor's protocol ID
- FR03001
- Status last verified
- May 2013
- First submitted
- 13 Sep 2005
- Last updated
- 8 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.
- ClinicalTrials.gov ID
- NCT00223977
- Acronym / sponsor ID
- FR03001
- Conditions
- Iron Deficiency Anemia
- Keywords
- Anemia.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 28 Sep 2009
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 phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium ferric gluconate complex 125 mg | Experimental | Drug: Sodium Ferric Gluconate Complex125 mg sodium ferric gluconate weekly x 8 weeks |
| Sodium ferric gluconate complex 250 mg | Experimental | Drug: Sodium Ferric Gluconate Complex250 mg sodium ferric gluconate complex weekly x 4 weeks |
| Oral iron | Active comparator | Drug: Oral Iron325 mg ferrous sulfate three times daily x 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, at least 18 years of age.
- Received maintenance peritoneal dialysis therapy for at least 4 weeks.
- Was expected to remain on peritoneal dialysis therapy for duration of study.
- Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
- Signed patient informed consent.
Key exclusion criteria (5 listed)
- Had a predetermined serum levels of Ferritin and TSAT
- Pregnant or lactating.
- Had a serious concomitant medical disorder incompatible with participation in the study.
- Had a known hypersensitivity to Ferrlecit or any of its components.
- Unable to cooperate or comply with the protocol.
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 |
|---|---|---|
| Sodium Ferric Gluconate ComplexAlso: Ferrlecit125 mg weekly x 8 weeks | Drug | Sodium ferric gluconate complex 125 mg |
| Sodium Ferric Gluconate ComplexAlso: Ferrlecit250 mg weekly x 4 | Drug | Sodium ferric gluconate complex 250 mg |
| Oral Iron325 mg ferrous sulfate orally three times daily x 8 weeks | Drug | Oral iron |
Primary outcome
Hemoglobin
Time frame: Baseline to 5 weeks and 9 weeks
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
4 secondary outcomes
Change From Baseline in Hematocrit (Hct)
Time frame: Baseline to 5 weeks and 9 weeks
Change From Baseline in Transferrin Saturation (TSAT).
Time frame: Baseline to 5 weeks and 9 weeks
Change From Baseline in Serum Ferritin.
Time frame: Baseline to 5 weeks and 9 weeks
Responders by Treatment Group
Time frame: Baseline to 5 weeks and 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- 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.
Gary Hoel, RPh, PhD study chair
Watson Pharmaceuticals
43 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium Ferric Gluconate Complex and Oral Iron in people with Iron Deficiency Anemia, run by Watson Pharmaceuticals at 43 sites in 8 countries.
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 5 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 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, India, Mexico, Canada, Bulgaria and 3 more countries. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Sep 2009). 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?
Hemoglobin (time frame: Baseline to 5 weeks and 9 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 8 Jul 2013.