AnemiaPhase 4NCT00223938
Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
A Phase 4 study testing Oral Iron and sodium ferric gluconate in people with Anemia, run by Sanofi at 8 sites in United States.
Trial summary
This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Oral Iron and sodium ferric gluconate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Dec 2003to 27 Apr 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male of female, 18 years old or older.
- Have been receiving chronic hemodialysis therapy
- On stable EPO dosing regimen.
- Have signed patient informed consent.
- Predetermined serum ferritin and TSAT levels.
- Clinical instability - inability to achieve adequate dialysis, abnormal serum albumin and serum glucose.
- Pregnant or lactating.
- A known sensitivity to Ferrlecit
Who cannot join
- Scheduled for renal transplant.
- A serious concomitant medical disorders incompatible with participation in the study.
- Unable to cooperate or comply with the protocol.
- Use of any investigation agent within 30 days prior to study or during the course of the study.
- Judged by the investigator as unsuitable for enrollment for any reason.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Canton, Ohio
Study site
Columbus, Ohio
Study site
Hot Springs, Arkansas
Study site
Orange County, California
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Simi Valley, California
Study site
Winston-Salem, North Carolina
About this study
Official title: A Multi-center, Open-label, Randomized, Parallel Group Study of the Efficacy and Safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin.
This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.
Read the detailed description
A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.
- Conditions
- Anemia
- Being tested
- Oral Iron, sodium ferric gluconate
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral IronDrug
Also called Ferrous sulfate
Oral Iron
sodium ferric gluconateDrug
Also called Ferrlecit
weekly intravenous injection Dose 1
sodium ferric gluconateDrug
Also called Ferrlecit
weekly intravenous injection Dose 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral Iron Receives: Drug: Oral Iron |
| 2 | Experimental | sodium ferric gluconate Receives: Drug: sodium ferric gluconate |
| 3 | Experimental | sodium ferric gluconate Receives: Drug: sodium ferric gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin.
Measured: 22 weeks
Secondary outcomes (1)
The secondary objectives of this study include comparisons between Ferrlecit treatments to oral iron regarding changes from baseline in hematological parameters, iron indices, EPO requirements and safety.
Measured: 22 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 start30 Dec 2003
- Primary completion27 Apr 2007
- Study completion27 Apr 2007
Why it stopped: The study was terminated because of significant enrollment challenges
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Hoel, RPh, PhD, Study director, Watson Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223938
- Sponsor's protocol ID
- FR02023
- Status last verified
- Jun 2021
- First submitted
- 13 Sep 2005
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized, Parallel Group Study of the Efficacy and Safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin.
- ClinicalTrials.gov ID
- NCT00223938
- Acronym / sponsor ID
- FR02023
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of significant enrollment challenges
- Enrolment
- 112 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2003 (actual)
- Primary completion
- 27 Apr 2007 (actual)
- Study completion
- 27 Apr 2007 (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 is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.
Detailed description
A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Oral IronOral Iron |
| 2 | Experimental | Drug: sodium ferric gluconatesodium ferric gluconate |
| 3 | Experimental | Drug: sodium ferric gluconatesodium ferric gluconate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male of female, 18 years old or older.
- Have been receiving chronic hemodialysis therapy
- On stable EPO dosing regimen.
- Have signed patient informed consent.
- Predetermined serum ferritin and TSAT levels.
Key exclusion criteria (5 listed)
- Scheduled for renal transplant.
- A serious concomitant medical disorders incompatible with participation in the study.
- Unable to cooperate or comply with the protocol.
- Use of any investigation agent within 30 days prior to study or during the course of the study.
- Judged by the investigator as unsuitable for enrollment for any reason.
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 |
|---|---|---|
| Oral IronAlso: Ferrous sulfateOral Iron | Drug | 1 |
| sodium ferric gluconateAlso: Ferrlecitweekly intravenous injection Dose 1 | Drug | 2 |
| sodium ferric gluconateAlso: Ferrlecitweekly intravenous injection Dose 2 | Drug | 3 |
Primary outcome
The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin.
Time frame: 22 weeks
1 secondary outcome
The secondary objectives of this study include comparisons between Ferrlecit treatments to oral iron regarding changes from baseline in hematological parameters, iron indices, EPO requirements and safety.
Time frame: 22 weeks
Results and safety
The study was stopped early (reason given: The study was terminated because of significant enrollment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
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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 Pharmaceuticals
8 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 Oral Iron and sodium ferric gluconate in people with Anemia, run by Sanofi at 8 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 8 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: stopped early, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study was stopped early (reason given: The study was terminated because of significant enrollment challenges). Results are not available in the source record.
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?
The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin. (time frame: 22 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 24 Jun 2021.