AnemiaPhase 4NCT00223964
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
A Phase 4 study testing Ferrlecit (sodium ferric gluconate complex in sucrose injection) in people with Anemia, run by Watson Pharmaceuticals at 24 sites in 5 countries.
Trial summary
This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Anemia
- What is being tested?
- Ferrlecit (sodium ferric gluconate complex in sucrose injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Jun 2003to Oct 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 end-stage renal disease (ESRD) patients.
- Predetermined TSAT and serum ferritin levels
- Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
- Receiving a stable epoetin (EPO) dosing regimen.
Who cannot join
- Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
- Blood transfusion.
- Hypersensitivity to Ferrlecit®.
- Significant inflammatory conditions.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Poland9 sites
Study site
Bialystok
Study site
Gdansk
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Szczecin
Study site
Torum
Study site
Wroclaw
Study site
Zabrze
United States8 sites
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
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
Russia4 sites
Study site
Bashkortostan
Study site
Moscow
Study site
Saint Petersburg
Study site
Tartarstan
About this study
Official title: Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.
This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.
- Conditions
- Anemia
- Being tested
- Ferrlecit (sodium ferric gluconate complex in sucrose injection)
- Keywords
- Iron Deficiency, Anemia in Pediatric Hemodialysis
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrlecit (sodium ferric gluconate complex in sucrose injection)Drug
| Study group | Role | What they receive |
|---|---|---|
| dose level 1 | Experimental | 1.5 mg/kg Receives: Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection) |
| dose level 2 | Experimental | 3 mg/kg Receives: Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.
Measured: 2 weeks
Secondary outcomes (1)
Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.
Measured: 48 hours
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 startJun 2003
- Primary completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GARY HOEL, RPh, PhD, Study director, WATSON LPHARMACEUTICAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223964
- Sponsor's protocol ID
- FR01006
- Status last verified
- Aug 2012
- First submitted
- 13 Sep 2005
- Last updated
- 14 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.
- ClinicalTrials.gov ID
- NCT00223964
- Acronym / sponsor ID
- FR01006
- Conditions
- Anemia
- Keywords
- Iron Deficiency, Anemia in Pediatric Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Oct 2003 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose level 1 | Experimental | Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)1.5 mg/kg |
| dose level 2 | Experimental | Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)3 mg/kg |
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 end-stage renal disease (ESRD) patients.
- Predetermined TSAT and serum ferritin levels
- Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
- Receiving a stable epoetin (EPO) dosing regimen.
Key exclusion criteria (4 listed)
- Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
- Blood transfusion.
- Hypersensitivity to Ferrlecit®.
- Significant inflammatory conditions.
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 |
|---|---|---|
| Ferrlecit (sodium ferric gluconate complex in sucrose injection) | Drug | dose level 1, dose level 2 |
Primary outcome
Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.
Time frame: 2 weeks
1 secondary outcome
Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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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 LPHARMACEUTICAL
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrlecit (sodium ferric gluconate complex in sucrose injection) in people with Anemia, run by Watson Pharmaceuticals at 24 sites in 5 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 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 14 Aug 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 Poland, United States, Russia, Mexico, Serbia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy. (time frame: 2 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 14 Aug 2012.