AnemiaPhase 3NCT00661999
Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer
A Phase 3 study testing darbepoetin alfa, ferrous sulfate and sodium ferric gluconate complex in sucrose in people with Anemia and Leukemia, run by Mayo Clinic at 2 sites in United States.
Trial summary
RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- darbepoetin alfa, ferrous sulfate and sodium ferric gluconate complex in sucrose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Mar 2009
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of a non-myeloid cancer (other than non-melanomatous skin cancer)
- Receiving or scheduled to receive chemotherapy (biological agents, such as small molecules/tyrosine kinase inhibitors and antibody-based therapies, are allowed)
- Has chemotherapy-related anemia (hemoglobin < 11 g/dL)
- No anemia known to be secondary to gastrointestinal bleeding or hemolysis
- No anemia known to be secondary to vitamin B12 or folic acid deficiency + Vitamin B12 and folic acid deficiency must be ruled out if the mean corpuscular volume (MCV) is > 100 fL
- No anemia secondary to chemotherapy-induced myelodysplastic syndromes
- No primary hematologic disorder causing moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major)
- Carriers for these disease states are eligible
- No first-degree relative with primary hemochromatosis (unless the patient has undergone HFE genotyping and was found to have at least one wild-type allele, while the proband in the family demonstrated to have either the common C282Y or H63D mutation)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Ferritin > 20 mcg/L (i.e., not obviously iron deficient)
- ALT or AST < 5 times upper limit of normal
- Alert, mentally competent, and able to sign informed consent
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Willing or able to be randomized and undergo study treatment
- Willing or able to fill out quality-of-life forms
- No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 180 mm Hg or diastolic BP ≥ 100 mm Hg)
- No history of uncontrolled cardiac arrhythmias
- No pulmonary embolism or deep venous thrombosis within the past year (unless the patient is on anticoagulation therapy and planning to continue it during study participation)
- No known hypersensitivity to darbepoetin alfa, erythropoietin, mammalian cell-derived products, iron, or human albumin
- No seizures within the past 3 months
- No gastrointestinal conditions expected to cause significant impairment of oral iron, such as untreated celiac disease or amyloidosis involving the gut - Patients with celiac disease who are adhering to a gluten-free diet are eligible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior darbepoetin alfa, epoetin alfa, or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis-stimulating protein)
- More than 1 year since prior peripheral blood stem cell or bone marrow transplantation
- More than 2 weeks since prior red blood cell transfusions
- More than 14 days since prior major surgery
- No prior gastrectomy or resection of > 100 cm of small intestine
- Not planning to undergo stem cell or bone marrow transplantation within the next 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona
About this study
Official title: A Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron, or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Cancer Patients With Chemotherapy-Associated Anemia
RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare the effects of IV iron, oral iron, or placebo in combination with darbepoetin alfa on the hematopoietic response rate, defined as a hemoglobin increment of ≥ 2.0 g/dL from baseline or achievement of hemoglobin of ≥ 11 g/dL in the absence of red blood cell transfusions (RBC) in the preceding 28 days of the treatment period, in cancer patients with chemotherapy-associated anemia.
Secondary
- To compare the effects of these regimens on the mean hemoglobin increment from baseline to weeks 7 and 16 in these patients.
- To compare the effects of these regimens on the percentage of patients maintaining an average hemoglobin level within the American Society of Hematology/American Society of Clinical Oncology (ASH/ASCO)and National Comprehensive Cancer Network(NCCN) guideline-based target hemoglobin range (11-13 g/dL), once achieving a hemoglobin of ≥ 11 g/dL from week 1 to week 16 in the absence of RBC transfusions in the preceding 28 days of the treatment period.
- To compare the effects of intravenously (IV) iron, oral iron, or placebo on the response to darbepoetin alfa, in terms of time to achieving hemoglobin levels of ≥ 11g/dL.
- To compare the effects of these regimens on the percentage of patients who require RBC transfusions and the total transfusion needs.
- To compare the effects of these regimens on the change in hemoglobin week by week.
- To compare the effects of these regimens on quality-of-life changes from baseline to weeks 7 and 16.
- To identify if patients with inflammation (as indicated by elevated C-reactive protein (CRP) and serum hepcidin levels or low soluble transferrin receptor (sTfR)/log ferritin ratios) respond differently to darbepoetin alfa and iron therapy than patients without inflammation.
OUTLINE: Patients are stratified according to severity of anemia (mild [hemoglobin ≥ 9.5 g/dL] vs severe [hemoglobin < 9.5 g/dL]), treatment with a platinum-containing regimen (yes vs no), and gender. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1.
- Arm II: Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21.
- Arm III: Patients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21.
In all arms, treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
Patients complete quality-of-life (QOL) questionnaires in weeks 1, 7, and 16.
- Conditions
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
- Being tested
- darbepoetin alfa, ferrous sulfate, sodium ferric gluconate complex in sucrose, placebo
- Keywords
- unspecified adult solid tumor, protocol specific, monoclonal gammopathy of undetermined significance, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, primary systemic amyloidosis, Waldenstrom macroglobulinemia, post-transplant lymphoproliferative disorder, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma
- Medical subject headings
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Precancerous Conditions, Monoclonal Gammopathy of Undetermined Significance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfaBiological
Given by injection
ferrous sulfateDietary supplement
Given by mouth
sodium ferric gluconate complex in sucroseDrug
Given by IV
placeboOther
Given by mouth
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. Receives: Biological: darbepoetin alfa; Drug: sodium ferric gluconate complex in sucrose |
| Arm II | Experimental | Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. Receives: Biological: darbepoetin alfa; Dietary Supplement: ferrous sulfate |
| Arm III | Experimental | Patients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. Receives: Biological: darbepoetin alfa; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response
Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
Measured: 16 Weeks
Secondary outcomes (15)
Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL
Measured: 16 Weeks
Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions
Measured: Week 1 to Week 16
Mean Increment in Hemoglobin Level at Week 7
Value at 7 weeks minus value at baseline.
Measured: Baseline and 7 weeks
Mean Increment in Hemoglobin Level at Week 16
Value at 16 weeks minus value at baseline.
Measured: Baseline and 16 weeks
Time to Hematopoietic Response
Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
Measured: 16 weeks
Time to First Red Blood Cell (RBC) Transfusions
Measured: 16 weeks
Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)
Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.
Measured: Baseline and 16 weeks
Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study
SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
Measured: Baseline and 16 weeks
Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study
Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.
Measured: Baseline and 16 weeks
Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study
FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
Measured: Baseline and 16 weeks
C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16
Measured: 1 Week, 7 Weeks and 16 Weeks
Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16
Measured: 1 week, 7 weeks and 16 weeks
Ferritin Level at Baseline, Week 7 and Week 16
Measured: Baseline, 7 weeks and 16 weeks
Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16
MCV is a measure of the average red blood cell volume.
Measured: Baseline, 7 weeks and 16 weeks
Transferrin Saturation at Baseline, Week 7 and Week 16
Measured: Baseline, 7 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2009
- Study completionMar 2009
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.
- More trials run by Mayo ClinicThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Charles L. Loprinzi, MD, Study chair, Mayo ClinicTom R. Fitch, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661999
- Sponsor's protocol ID
- CDR0000593480
- Other IDs
- P30CA015083, MC04CC, NCI-2009-01226, 1713-05
- Status last verified
- May 2011
- First submitted
- 18 Apr 2008
- Last updated
- 17 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron, or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Cancer Patients With Chemotherapy-Associated Anemia
- ClinicalTrials.gov ID
- NCT00661999
- Acronym / sponsor ID
- CDR0000593480
- Conditions
- Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
- Keywords
- unspecified adult solid tumor, protocol specific, monoclonal gammopathy of undetermined significance, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 18 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.
Detailed description
OBJECTIVES:
Primary
- To compare the effects of IV iron, oral iron, or placebo in combination with darbepoetin alfa on the hematopoietic response rate, defined as a hemoglobin increment of ≥ 2.0 g/dL from baseline or achievement of hemoglobin of ≥ 11 g/dL in the absence of red blood cell transfusions (RBC) in the preceding 28 days of the treatment period, in cancer patients with chemotherapy-associated anemia.
Secondary
- To compare the effects of these regimens on the mean hemoglobin increment from baseline to weeks 7 and 16 in these patients.
- To compare the effects of these regimens on the percentage of patients maintaining an average hemoglobin level within the American Society of Hematology/American Society of Clinical Oncology (ASH/ASCO)and National Comprehensive Cancer Network(NCCN) guideline-based target hemoglobin range (11-13 g/dL), once achieving a hemoglobin of ≥ 11 g/dL from week 1 to week 16 in the absence of RBC transfusions in the preceding 28 days of the treatment period.
- To compare the effects of intravenously (IV) iron, oral iron, or placebo on the response to darbepoetin alfa, in terms of time to achieving hemoglobin levels of ≥ 11g/dL.
- To compare the effects of these regimens on the percentage of patients who require RBC transfusions and the total transfusion needs.
- To compare the effects of these regimens on the change in hemoglobin week by week.
- To compare the effects of these regimens on quality-of-life changes from baseline to weeks 7 and 16.
- To identify if patients with inflammation (as indicated by elevated C-reactive protein (CRP) and serum hepcidin levels or low soluble transferrin receptor (sTfR)/log ferritin ratios) respond differently to darbepoetin alfa and iron therapy than patients without inflammation.
OUTLINE: Patients are stratified according to severity of anemia (mild [hemoglobin ≥ 9.5 g/dL] vs severe [hemoglobin < 9.5 g/dL]), treatment with a platinum-containing regimen (yes vs no), and gender. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1.
- Arm II: Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21.
- Arm III: Patients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21.
In all arms, treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
Patients complete quality-of-life (QOL) questionnaires in weeks 1, 7, and 16.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: darbepoetin alfa, Drug: sodium ferric gluconate complex in sucrosePatients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Arm II | Experimental | Biological: darbepoetin alfa, Dietary Supplement: ferrous sulfatePatients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Arm III | Experimental | Biological: darbepoetin alfa, Other: placeboPatients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| darbepoetin alfaGiven by injection | Biological | Arm I, Arm II, Arm III |
| ferrous sulfateGiven by mouth | Dietary supplement | Arm II |
| sodium ferric gluconate complex in sucroseGiven by IV | Drug | Arm I |
| placeboGiven by mouth | Other | Arm III |
Primary outcome
Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response
Time frame: 16 Weeks
Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
15 secondary outcomes
Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL
Time frame: 16 Weeks
Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions
Time frame: Week 1 to Week 16
Mean Increment in Hemoglobin Level at Week 7
Time frame: Baseline and 7 weeks
Mean Increment in Hemoglobin Level at Week 16
Time frame: Baseline and 16 weeks
Time to Hematopoietic Response
Time frame: 16 weeks
Time to First Red Blood Cell (RBC) Transfusions
Time frame: 16 weeks
Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)
Time frame: Baseline and 16 weeks
Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study
Time frame: Baseline and 16 weeks
Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study
Time frame: Baseline and 16 weeks
Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study
Time frame: Baseline and 16 weeks
C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16
Time frame: 1 Week, 7 Weeks and 16 Weeks
Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16
Time frame: 1 week, 7 weeks and 16 weeks
Ferritin Level at Baseline, Week 7 and Week 16
Time frame: Baseline, 7 weeks and 16 weeks
Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16
Time frame: Baseline, 7 weeks and 16 weeks
Transferrin Saturation at Baseline, Week 7 and Week 16
Time frame: Baseline, 7 weeks and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- 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.
Charles L. Loprinzi, MD study chair
Mayo Clinic
Tom R. Fitch, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing darbepoetin alfa, ferrous sulfate and sodium ferric gluconate complex in sucrose in people with Anemia and Leukemia, run by Mayo Clinic at 2 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?
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 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 18 Apr 2011). 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?
Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response (time frame: 16 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 17 May 2011.