Non-anemic Patients Undergoing Elective or Sub-Acute CABG, Valve Replacement or a Combination thereof MedDRA version: 14.1 Level: LLT Classification code 10054312 Term: Anemia postoperative System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Monofer, injektions- og infusionsvæske, opløsning
Product Name: Monofer
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Iron Isomaltoside 1000
CAS Number: 9004-66
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be suitable for inclusion in the study, the subjects meet the following criteria: 1. Men and women over 18 years. 2. Non-anemic Patients undergoing elective or subacute CABG, heart valve replacement or a combination thereof. 3. Women: Hb = 12.0 g / dl (7.45 mmol / l), men: Hb = 13.0 g / dl (8.1 mmol / l). 4. Willingness to participate after 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Individuals who meet one or more of the following criteria are unsuitable for inclusion in the study: 1. Participants who have received blood transfusion within 30 days prior to screening, and / or during the elective CABG or subacute, heart valve replacement, or a combination thereof. 2. Iron Overload or disturbances in utilization of iron (eg. Haemochromatosis and haemosiderosis) 3. Serum ferritin> 800 ng / ml. 4. Known hypersensitivity to any of the excipients of the study drug. 5. Multiple allergies in medical history. 6. Decompensated cirrhosis and hepatitis. 7. Alanine aminotransferase (ALT)> 3 times upper limit of normal. 8. Acute infections (after clinical assessment). 9. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 10. The patient is pregnant or breast-feeding. (To exclude pregnancy, women must be postmenopausal (at least 12 months since the last menstrual period) or sterilized or, for women of childbearing potential, use one of the following methods of contraception throughout the trial and for a period after termination representing at least 5 biological plasma half-lives of study drug: P contraceptives, intrauterine devices, parenteral contraception with depot effect (prolonged release formulation with progestin), subdermal implant, vaginal ring or transdermal patches). 11. Participation in another clinical trial, in a period prior to screening corresponding to less than 5 half-lives of the experimental drug. 12. Untreated Vitamin B12 or folate deficiency. 13. Another iv or oral iron therapy within 4 weeks prior to screening visit. 14. Erythropoietin treatment within 4 weeks prior to screening visit. 15. Impaired renal function defined by se-creatinine> 150µmol / l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo in leading to a less decrease in the haemoglobin level in non-anemic patients undergoing cardiac surgery;Secondary Objective: • The secondary purpose of the study is to compare the effect of jernisomaltosid 1000 and placebo on: ? Need for blood transfusion ? Iron Related Parameters ? Time of Hospitalization ? Functional capabilities ? Safety;Primary end point(s): The trial's primary endpoint is: ? Changes in hemoglobin concentration from baseline (ie preoperatively - the day before surgery or surgery day) for 4 weeks postoperatively.;Timepoint(s) of evaluation of this end point: 4 weeks postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points of the study are: • Proportion of patients that are anaemic (women < 12 g/dL and men < 13 g/dL) at day 5 and week 4 • Proportion of patients able to maintain Hb between 9.5 and 12.5 g/dL (both values included) at day 5 and week 4. • Number of patients in each randomisation group who need blood transfusion and number of transfusions administered • Change from baseline (preoperatively - the day before surgery or same day) in concentrations of serum ferritin, serum iron, TfS, and reticulocytes at day 5 and week 4 • Number of postoperative days to discharge • Changes in New York Heart Association (NYHA) classification from baseline to 4 weeks post operatively • Number of patients in each randomisation group who experience any study drug related adverse events (AEs/SAEs/SUSARs) ;Timepoint(s) of evaluation of this end point: 4 weeks postoperatively | — |
Countries
Denmark
Contacts
Public ContactCMO
Pharmacosmos A/S
Outcome results
None listed