Open randomized study to evaluate the efficacy of i.v. iron support (ferrum gluconate, 125 mg i.v. infusion weekly for 6 weeks) in primary solid tumour patients (breast, lung, colon-rectum and gynecological) treated with darbepoetin alfa (150 mcg once weekly subcutaneous for 12 weeks)for neoplastic chemotherapy related anaemia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002176-42-IT

Enrollment

420

Registered

2005-05-12

Start date

2004-11-30

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Treatment of the anaemia in adult patients affected by non mieloid-tumours receiving chemotherapy. MedDRA version: 6.1 Level: SOC Classification code 10029104

Interventions

Trade Name: NESPO* 1 SIR. 0,3 ML 150MCG Product Name: NA Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: darbopoetin alfa CAS Number: 209810-58-2 Current Sponsor code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026