AnemiaPhase 3NCT00236951
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
A Phase 3 study testing iron sucrose injection USP and stable erythropoietin therapy in people with Anemia, run by American Regent, Inc..
Trial summary
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- iron sucrose injection USP and stable erythropoietin therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Dec 2005
- Phase
- Phase 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
- Histological Diagnosis of Cancer
- Hgb </= 10
- Ongoing or Planned Chemotherapy
- Body Weight >50kg
- Free of Active Infection
- Karnofsky Status 60% to 100%
Who cannot join
- Active infection
- Use of Multivitamins with iron within one week of entry
- Myelophthisic bone marrow involvement by tumor except hematologic malignancy
- Concurrent medical condition that would prevent compliance or jeopardize the health of the patient
- Use of any IV iron products within two months of study entry
- Blood Transfusions
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- Hypoplastic bone marrow failure state
- Acute Leukemia
- Myeloproliferative syndrome
- Uncontrolled hypertension
About this study
Official title: A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
Read the detailed description
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.
- Conditions
- Anemia
- Being tested
- iron sucrose injection USP, stable erythropoietin therapy
- Keywords
- Anemia, Cancer, Chemotherapy
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron sucrose injection USPDrug
stable erythropoietin therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Venofer + erythropoietin (responders) | Active comparator | Not described Receives: Drug: iron sucrose injection USP |
| erythropoietin only (responders) | Active comparator | Not described Receives: Drug: stable erythropoietin therapy |
| Venofer+erythropoietin(non-responders) | Active comparator | Not described Receives: Drug: iron sucrose injection USP |
| erythropoietin only (non-responders) | Active comparator | Not described Receives: Drug: stable erythropoietin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
Measured: During Stage 2 (week 9 through week 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startFeb 2003
- Primary completionOct 2005
- Study completionDec 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 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236951
- Sponsor's protocol ID
- 1VEN02023
- Status last verified
- Jan 2018
- First submitted
- 10 Oct 2005
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
- ClinicalTrials.gov ID
- NCT00236951
- Acronym / sponsor ID
- 1VEN02023
- Conditions
- Anemia
- Keywords
- Anemia, Cancer, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Dec 2005
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 23 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
Detailed description
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Venofer + erythropoietin (responders) | Active comparator | Drug: iron sucrose injection USP |
| erythropoietin only (responders) | Active comparator | Drug: stable erythropoietin therapy |
| Venofer+erythropoietin(non-responders) | Active comparator | Drug: iron sucrose injection USP |
| erythropoietin only (non-responders) | Active comparator | Drug: stable erythropoietin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological Diagnosis of Cancer
- Hgb </= 10
- Ongoing or Planned Chemotherapy
- Body Weight >50kg
- Free of Active Infection
Key exclusion criteria (10 listed)
- Active infection
- Use of Multivitamins with iron within one week of entry
- Myelophthisic bone marrow involvement by tumor except hematologic malignancy
- Concurrent medical condition that would prevent compliance or jeopardize the health of the patient
- Use of any IV iron products within two months of study entry
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 |
|---|---|---|
| iron sucrose injection USP | Drug | Venofer + erythropoietin (responders), Venofer+erythropoietin(non-responders) |
| stable erythropoietin therapy | Drug | erythropoietin only (non-responders), erythropoietin only (responders) |
Primary outcome
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
Time frame: During Stage 2 (week 9 through week 21)
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iron sucrose injection USP and stable erythropoietin therapy in people with Anemia, run by American Regent, Inc..
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 6 inclusion and 10 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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 23 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?
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). (time frame: During Stage 2 (week 9 through week 21)). 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 20 Feb 2018.