Clinical trial · Interventional
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
NCT00236951CI-TRIAL-00031743completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iron sucrose injection USP | Drug | — | UNRESOLVED |
| stable erythropoietin therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Venofer + erythropoietin (responders)
- interventionNames
- Drug: iron sucrose injection USP
- type
- ACTIVE_COMPARATOR
- label
- erythropoietin only (responders)
- interventionNames
- Drug: stable erythropoietin therapy
- type
- ACTIVE_COMPARATOR
- label
- Venofer+erythropoietin(non-responders)
- interventionNames
- Drug: iron sucrose injection USP
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological Diagnosis of Cancer * Hgb \</= 10 * Ongoing or Planned Chemotherapy * Body Weight \>50kg * Free of Active Infection * Karnofsky Status 60% to 100% Exclusion Criteria: * 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 * Hypoplastic bone marrow failure state * Acute Leukemia * Myeloproliferative syndrome * Uncontrolled hypertension
References
Publications (0)
Data not yet available
No reference posted for this study.