Iron deficiency anaemia and anaemia of chronic disease MedDRA version: 17.1 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851 MedDRA version: 17.1 Level: LLT Classification code 10020970 Term: Hypochromic anaemia of chronic disease System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Monofer
Product Name: Monofer
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: IRON(III) ISOMALTOSIDE 1000
CAS Number: 9004-66-04
Other descriptive name: IRON(III)
Sponsors
Rigshospitalet, 2032
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Anaemia: males Hb 18 years •Iron deficiency anaemia and anaemia of chronic disease: P-Ferritin=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: •Anaemia3x normal) •Rheumatoid arthritis with symptoms or signs of acute inflammation (assessed by clinical judgement and CRP) •Haemosiderosis or haemochromatosis •RBC transfusion two weeks prior inclusion •Intravenous iron or ESA four weeks prior inclusion •Uraemia with creatinine>250 umol/L or haemodialysis •Pregnancy •Participating in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of intravenous iron versus placebo on preoperative anaemia in patients with urogenital cancer;Secondary Objective: 1) To treat anaemia preoperative 2) To increase Hb concentration postoperatively 3) To treat anaemia postoperatively 4) To reduce RBC tranfusion rate 5) To reduce the RBC transfusion volume 6) To correct the iron deficit preoperative and postoperative 7) To evaluate the effect on fatigue preoperative and postoperative 8) To calculate the frequence of infections postoperative 9) To calculate the lenght of stay in the hospital 10) To compare the change in Hb levels between the two groups;Primary end point(s): The proportion of patients with a mean increase in Hb level > 0.97 g/dL (0.6mmol/L) or who normalize Hb concentration from the day of intervention to the day before surgery;Timepoint(s) of evaluation of this end point: Approximately 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of patients with Hb level within normal range the day before surgery (male> 13.4 g/dL (8.3 mmol/L), female> 11.8 g/dL (7.3 mmol/L)) 2. The proportion of patients with a mean increase in Hb level > 0.97 g/dL (0.6mmol/L) from the day of intervention to two weeks postoperative 3. The proportion of patients with Hb level within normal range two weeks postoperative (male> 13.4 g/dL (8.3 mmol/L), female> 11.8 g/dL (7.3 mmol/L)) 4. Reduction of the rate of RBC transfusion (percentage of patients with RBC transfusion from the day before surgery to last visit) 5. Reduction of RBC transfusion requirement (number of RBC transfusions per transfused patient from the day before surgery to last visit). 6. The proportion of patients (with P-ferritin 100 ug/L and TSAT >20 %) the day before surgery and two weeks postoperative 7. Significant change in fatigue symptoms measured by quality of life (QLQ) and fatigue questionnaires the day before surgery and two weeks postoperative 8. The propotion of patients with infections after surgery. 9. Lenght of stay in the hospital in days 10. Comparison of the change of ?Hb between the two groups ;Timepoint(s) of evaluation of this end point: Approximately 2-4 weeks | — |
Countries
Denmark
Contacts
Public ContactBlood Bank 2032, Rigshospitalet
Trine Stissing
Outcome results
None listed