Fe deficiency anaemia MedDRA version: 9.1 Level: PT Classification code 10002034 Term: Anaemia
Conditions
Interventions
Trade Name: CosmoFer®
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Iron III-hydroxide dextran
CAS Number: 18624447
Current Sponsor code: Cosmofer
Other descriptive name: FERROUS HYDR
Sponsors
Hospital Errikos Dunant- Department of Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of the combination of EPO and TDI of CosmoFer® to the combination of EPO and oral Fe for the correction of anaemia and re-plenishment of Fe stores in patients with haematological malignancies by comparing the mean change in Hb g/dl levels from baseline to week eight.;Primary end point(s): The primary efficacy endpoint is the mean change of Hb (g/dl) from baseline to EOS (week eight) or to the time of early withdrawal. ;Secondary Objective: To compare the safety of the combination of EPO and TDI of CosmoFer® to the com-bination of EPO and standard oral Fe for: The correction of anaemia in patients with haematological malignancies. The correction of anaemia in patients with haemato-logical malignancies by comparing the mean change in Hb g/dl levels from baseline to week two and four. The correction of anaemia in patients with haemato-logical malignancies by comparing number of erythroid responders (defined as an in-crease in Hb levels by at least 2 g/dL compared to baseline) after two, four, and eight weeks of treatment in the two treatment arms. The correction of anaemia in patients with haemato-logical malignancies by comparing other parameters of haemopoiesis (Hct, RTLCs, se-rum Fe, TSAT, serum Ferritin, MCH, MCHC, and MCV) after two, four and eight weeks of treatment in the two treatment arms. | — |
Countries
Greece
Outcome results
None listed