Anemia, Iron-DeficiencyPhase 4NCT00224042
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
A Phase 4 study testing Sodium Ferric Gluconate complex in sucrose and Ferrous sulfate tablets in people with Anemia, Iron-Deficiency and Kidney Failure, Chronic, run by Watson Pharmaceuticals at 24 sites in 2 countries.
Trial summary
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron-Deficiency, Kidney Failure, Chronic
- What is being tested?
- Sodium Ferric Gluconate complex in sucrose and Ferrous sulfate tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Apr 2003to May 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe anemia
- Iron deficiency
- Moderate to severe chronic kidney disease
- Receiving therapy with erythropoietic agent
Who cannot join
- Receiving dialysis
- Known sensitivity to Ferrlecit® or any of its components
- Clinically unstable
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Chapel Hill, North Carolina
Study site
Charlotte, South Carolina
Study site
Chattanooga, Tennessee
Study site
Cleveland, Ohio
Study site
Detroit, New York
Study site
Fairfax, Virginia
Study site
Hines, Illinois
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Mineola, New York
Study site
New York, New York
Study site
Palo Alto, California
Study site
Philadelphia, Pennsylvania
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
Springfield, Massachusetts
Study site
St Louis, Missouri
Study site
The Bronx, New York
Study site
Tucson, Arizona
About this study
Official title: A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.
- Conditions
- Anemia, Iron-Deficiency, Kidney Failure, Chronic
- Being tested
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Keywords
- Iron deficiency, Anemia, Chronic kidney disease, Erythropoietic agents, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy, Erythropoietin, Recombinant/adverse effects/therapeutic use
- Medical subject headings
- Anemia, Iron-Deficiency, Kidney Failure, Chronic, Iron Deficiencies, Anemia, Renal Insufficiency, Chronic, Renal Insufficiency, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Ferric Gluconate complex in sucroseDrug
Also called Ferrlecit
Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
Ferrous sulfate tabletsDrug
ferrous sulfate 325 mg three times daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| IV iron | Experimental | Not described Receives: Drug: Sodium Ferric Gluconate complex in sucrose |
| oral iron | Active comparator | Not described Receives: Drug: Ferrous sulfate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Hemoglobin Concentration
Measured: Baseline
Change in Hemoglobin (Hgb)
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Measured: Baseline to 10 weeks
Secondary outcomes (2)
Baseline Serum Ferritin Concentration
Measured: Baseline
Change in Serum Ferritin
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Measured: Baseline to 10 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 startApr 2003
- Primary completionMay 2005
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 Anemia, Iron-DeficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adel R Rizkala, PharmD, MS, Study director, Watson Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224042
- Sponsor's protocol ID
- FER0201
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- Last updated
- 29 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy
- ClinicalTrials.gov ID
- NCT00224042
- Acronym / sponsor ID
- FER0201
- Conditions
- Anemia, Iron-Deficiency, Kidney Failure, Chronic
- Keywords
- Iron deficiency, Anemia, Chronic kidney disease, Erythropoietic agents, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy, Erythropoietin, Recombinant/adverse effects/therapeutic use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- May 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 29 Mar 2012
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 effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV iron | Experimental | Drug: Sodium Ferric Gluconate complex in sucrose |
| oral iron | Active comparator | Drug: Ferrous sulfate tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe anemia
- Iron deficiency
- Moderate to severe chronic kidney disease
- Receiving therapy with erythropoietic agent
Key exclusion criteria (3 listed)
- Receiving dialysis
- Known sensitivity to Ferrlecit® or any of its components
- Clinically unstable
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 complex in sucroseAlso: FerrlecitSodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses | Drug | IV iron |
| Ferrous sulfate tabletsferrous sulfate 325 mg three times daily for 6 weeks | Drug | oral iron |
Primary outcome
Baseline Hemoglobin Concentration
Time frame: Baseline
Change in Hemoglobin (Hgb)
Time frame: Baseline to 10 weeks
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
2 secondary outcomes
Baseline Serum Ferritin Concentration
Time frame: Baseline
Change in Serum Ferritin
Time frame: Baseline to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Adel R Rizkala, PharmD, MS study director
Watson Laboratories, Inc.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Ferric Gluconate complex in sucrose and Ferrous sulfate tablets in people with Anemia, Iron-Deficiency and Kidney Failure, Chronic, run by Watson Pharmaceuticals at 24 sites in 2 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 4 inclusion and 3 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 29 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 24 sites in United States, Puerto Rico. 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 29 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?
Baseline Hemoglobin Concentration (time frame: Baseline). The study lists 2 primary outcomes in all. 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 29 Mar 2012.