A comparative study of low molecular weight IV iron dextran (CosmoFer®) versus per os iron for the treatment of anaemia in patients with haematological malignancies receiving epoietin treatment

• Conditions: Fe deficiency anaemia; MedDRA version: 9.1Level: PTClassification code 10002034Term: Anaemia

• Registration Number: EUCTR2007-005777-57-GR
• Lead Sponsor: Hospital Errikos Dunant- Department of Hematology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Patients with newly diagnosed CLL, lymphoma (both Hodgkin’s and Non Hodgkin’s lymphoma) or MDS (RA, RAS, RAEB, and CMML) with a need for Fe due to anaemia and ESA treatment
Age = 18 years at screening
Hb = 11 g/dL
Serum Ferritin < 800 µgram/l
TSAT < 30 %
MCV < 85
ECOG PS 0-2
Life expectancy beyond 12 months
Willingness to participate after written informed consent

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

Non-Fe deficiency anaemia (Vitamin B12 deficiency, folic acid deficiency, gastrointestinal bleeding, or hemolysis)
Fe overload or disturbances in utilisation of Fe (e.g. haemochromatosis and haemosiderosis)
Previous hypersensitivity to Fe Dextran or Fe mono- or disaccharide complexes
Patients with a history of asthma, eczema, or other atopic allergies
Decompensated liver cirrhosis and hepatitis (ALAT > 3 times normal)
Acute or chronic infections (evaluated by clinical judgement derived by WBC and CRP if deemed necessary by investigator)
Rheumatoid arthritis with symptoms or signs of active inflammation
Pregnancy or nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
Planned elective surgery during the study where significant blood loss is expected
Participation in any other clinical trial within three months prior to screening
Uncontrolled hypertension (> 140/90 mmHg) despite optimal therapy
Known epilepsy
Renal dysfunction (serum creatinine > 2.0 mg/dl)
Prior RBC transfusion within the past two weeks
Prior Fe dextran treatment within the past four weeks
Prior EPO treatment within the past four weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified