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Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

This study has been terminated.
Information provided by:
Institut Claudius Regaud Identifier:
First received: September 12, 2005
Last updated: November 13, 2006
Last verified: November 2006
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.

Condition Intervention Phase
Neoplasms Anemia Drug: Darbepoetin alfa (Aranesp®) Drug: Ferric saccharose(Venofer®) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

Resource links provided by NLM:

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • Biological response rate for each group.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 55
Study Start Date: November 2003
Estimated Study Completion Date: April 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00210002

Centre Hospitalier de Castres
Castres, France
Centre Hospitalier de Montauban
Montauban, France
Centre Hospitalier Joseph Ducuing
Toulouse, France
Institut Claudius Regaud
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Principal Investigator: Roland Dugat, Pr Institut Claudius Regaud
  More Information Identifier: NCT00210002     History of Changes
Other Study ID Numbers: 03 DIVE 01
Study First Received: September 12, 2005
Last Updated: November 13, 2006

Keywords provided by Institut Claudius Regaud:
darbepoetin alfa
ferric saccharose

Additional relevant MeSH terms:
Hematologic Diseases
Ferric oxide, saccharated
Darbepoetin alfa
Hematinics processed this record on August 21, 2017