A randomized, dobbelblind, controlled trial comparing the effect on hemoglobin level by administration of an iron supplement (Monofer ®) into a vein versus placebo (saline) in non-anemic patients in connection with the execution of planned or sub-acute heart bypass surgery (CABG) , heart valve replacement, or a combination thereof.

Phase 1

• Conditions: on-anemic Patients Undergoing Elective or Sub-Acute CABG, Valve Replacement or a Combination thereof; MedDRA version: 14.1Level: LLTClassification code 10054312Term: Anemia postoperativeSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-023788-16-DK
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-09
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

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