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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00210002

Enrollment

Registered

2005-09-21

Start date

2003-11-30

Completion date

2006-04-30

Last updated

2006-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Neoplasms

Keywords

Neoplasms, Solid, Anemia, darbepoetin alfa, ferric saccharose, Venofer®, Aranesp®

Brief summary

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.

Interventions

DRUGDarbepoetin alfa (Aranesp®)

DRUGFerric saccharose(Venofer®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Biological response rate for each group.	—

Secondary

Measure	Time frame
To determine tolerance for ferric saccharose (Venofer®)	—
To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)	—
To determine percentage of hemoglobin rate's correction	—
To determine biological parameters's evolution	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026