Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease

NCT ID: NCT01599702

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

Brief Summary

The study is a prospective, non-controlled, open-label multi-centre pilot safety study of iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion, whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into two administrations.

Detailed Description

Subjects with a diagnosis of IBD (Crohn's disease or ulcerative colitis) and IDA ( Iron Deficiency Anaemia) with or without concomi-tant inflammation will be enrolled to receive a high dose of IV iron isomaltoside 1000.

Conditions

Inflammatory Bowel Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Group A Monofer

Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 where 1,500 mg is administered as a single infusion and 2,000 mg is divided into 2 administrations: 1 administration of 1,500 mg at baseline and 1 administration of 500 mg 1 week later. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes.

Group Type: EXPERIMENTAL

Iron Isomaltoside 1000

Intervention Type: DRUG

1500-3000mg IV depending on HB level, sex and body weight

Group B Monofer

Depending on the body weight, Subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into 2 administrations; 1 administration of 1,500 mg and 8 weeks later a second administration of 1,000 mg or 1,500 mg.. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes.

Group Type: EXPERIMENTAL

Iron Isomaltoside 1000

Intervention Type: DRUG

1500-3000mg IV depending on HB level, sex and body weight

Interventions

Iron Isomaltoside 1000

1500-3000mg IV depending on HB level, sex and body weight

Intervention Type: DRUG

Other Intervention Names

Monofer

Eligibility Criteria

Inclusion Criteria

1. Subjects with age ≥ 18 years

2. Subjects diagnosed with IBD either in remission or active

3. Hb < 12 g/dL for women and Hb < 13 g/dL for men

4. Subjects with a CRP above upper limit of normality must have a ferritin below 100 µg/L, whereas subjects with a CRP below or equal to upper limit of normality must have a ferritin below 30 µg/L

5. Willingness to participate after signing informed consent

Exclusion Criteria

1. Patient judged by the physician to be in need of surgery due to Crohn´s disease or ulcerative colitis within the next 2 months

2. Anaemia predominantly caused by factors other than IDA

3. Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis)

4. Known hypersensitivity to any excipients of iron isomaltoside 1000

5. History of multiple allergies

6. Decompensated liver cirrhosis and/or known chronic viral hepatitis (defined as Alanine Aminotransferase (ALAT) > 3 times upper limit of normal)

7. Acute and/or chronic infections

8. Body weight < 50 kg

9. Rheumatoid arthritis with symptoms or signs of active joint inflammation

10. Pregnancy and nursing. In order to avoid pregnancy, women have to be postmenopausal, surgically sterile, or use one of the following contraceptives during the whole study period and 5 days after the study has ended (i.e. 5 times plasma biological half-life of the investigational medicinal product): intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)

11. Blood transfusion within the previous 12 weeks

12. Subjects with a history of asthma, allergic eczema, or other atopic allergy

13. Planned elective surgery during the study

14. Untreated Vitamin B12 or folate deficiency, defined as values below the lower reference range

15. Participation in any other clinical study within 3 months prior to Screening

16. IV iron treatment within 8 weeks prior to Screening

17. Oral iron treatment within 1 week prior to Screening

18. Erythropoiesis Stimulating Agent (ESA) treatment within 8 weeks prior to Screening

19. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacosmos A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pharmacosmos A/S

Hoelbaek, , Denmark

Countries

Denmark

Other Identifiers

P-Monofer-IBD-02

Identifier Type: -

Identifier Source: org_study_id