Clinical trial · Interventional
Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.
NCT00210002CI-TRIAL-00000512terminatedPhase 2ClinicalTrials.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)
The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.
Conditions
Conditions (2)
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 | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alfa (Aranesp®) | Drug | — | UNRESOLVED |
| Ferric saccharose(Venofer®) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Biological response rate for each group.
Secondary outcomes (4)
- measure
- To determine tolerance for ferric saccharose (Venofer®)
- measure
- To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
- measure
- To determine percentage of hemoglobin rate's correction
- measure
- To determine biological parameters's evolution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Well-informed written consent, signed by the patient * Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis * Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9\<Hb\<12 g/dl; Women: 9\<Hb\<11 g/dl. * Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study * Patients with life expectancy higher than three months * Patient with general conditions compatible with the study's follow-up Exclusion Criteria: * Contra-indication for Venofer * Anemia which can have curative treatment * Bloody transfusion during the previous four weeks * Documented or suspected medullary invasion * Uncontrolled arterial hypertension * Acute bacterial infection * Transferrin saturation's coefficient * Pregnancy * Ferric salts oral treatment interrupted since less than one week * Patient with bad french language's comprehension * Patient with a major psychiatric pathology * Patient under guardianship, trusteeship or justice safeguard
References
Publications (0)
Data not yet available
No reference posted for this study.