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

Inflammatory Bowel Disease Clinical Trial

— IBD-02  

Official title:

A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease (PROMISE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599702
• Other study ID #: P-Monofer-IBD-02
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2012
• Last updated: April 28, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Den Nationale Videnskabsetiske KomitéSweden: Medical Products AgencySweden:Regionala Etikprövningsnämden i Lund.The Netherlands: Medische Ethische Toetsings CommissieThe Netherlands: CCMO (centrale commissie mensgebonden onderzoek)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Iron Isomaltoside 1000
1500-3000mg IV depending on HB level, sex and body weight

Locations

Country	Name	City	State
Denmark	Pharmacosmos A/S	Hoelbaek

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron isomaltoside 1000 in subjects with IDA secondary to IBD.	type and incidence of adverse drug reactions (ADRs)	up to 16 weeks	Yes
Secondary	To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000	obtain a target Hb (= 13 g/dL in men and = 12g/dL in women)	up to 16 weeks	No