AnemiaPhase 4NCT00224003
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
A Phase 4 study testing Sodium Ferric Gluconate Complex in Sucrose. in people with Anemia, run by Watson Pharmaceuticals at 10 sites in United States.
Trial summary
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Anemia
- What is being tested?
- Sodium Ferric Gluconate Complex in Sucrose.
- How many people
- 23 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2003to Feb 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
- Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
- Predetermined TSAT and serum Ferritin (at the screening visit).
- Receiving a stable EPO dosing regimen.
Who cannot join
- Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
- Hypersensitivity to Ferrlecit or any of its inactive components.
- High TSAT level.
- High Serum Ferritin
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Atlanta, Georgia
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Dallas, Texas
Study site
Kansas City, Missouri
Study site
Los Angeles, California
Study site
San Diego, California
Study site
Seattle, Washington
Study site
Stanford, California
Study site
The Bronx, New York
About this study
Official title: Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.
- Conditions
- Anemia
- Being tested
- Sodium Ferric Gluconate Complex in Sucrose.
- Keywords
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Ferric Gluconate Complex in Sucrose.Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Ferritin
Change from baseline to 2 weeks after last Fe dose
Measured: 14 weeks
Transferrin Saturation
Change from baseline to 2 weeks after last dose
Measured: 14 weeks
Secondary outcomes (1)
Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
Measured: 14 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 completionMar 2004
- Study completionFeb 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.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Hoel, RPh, PhD, Study director, Watson Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224003
- Sponsor's protocol ID
- FRO2001
- Other IDs
- FDA
- Status last verified
- Aug 2009
- First submitted
- 13 Sep 2005
- Last updated
- 28 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.
PubMed 16520948
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin
- ClinicalTrials.gov ID
- NCT00224003
- Acronym / sponsor ID
- FRO2001
- Conditions
- Anemia
- Keywords
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Feb 2005 (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.
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
- Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
- Predetermined TSAT and serum Ferritin (at the screening visit).
- Receiving a stable EPO dosing regimen.
Key exclusion criteria (4 listed)
- Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
- Hypersensitivity to Ferrlecit or any of its inactive components.
- High TSAT level.
- High Serum Ferritin
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 Sucrose. | Drug | – |
Primary outcome
Serum Ferritin
Time frame: 14 weeks
Change from baseline to 2 weeks after last Fe dose
Transferrin Saturation
Time frame: 14 weeks
Change from baseline to 2 weeks after last dose
1 secondary outcome
Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16520948Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.
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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 director
Watson Laboratories, Inc.
10 sites in 1 country: 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. in people with Anemia, run by Watson Pharmaceuticals at 10 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 4 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 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 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?
Serum Ferritin (time frame: 14 weeks). 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?
On the ClinicalTrials.gov record for NCT00224003, which also lists 1 linked publication.
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 28 Sep 2009.