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

NCT01599702 | Completed Phase 3

• 1 other identifier: P-Monofer-IBD-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

IBD; IDA; Subjects; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000

  up to 16 weeks

Study Arms (2)

Group A Monofer

EXPERIMENTAL

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.

Drug: Iron Isomaltoside 1000

Group B Monofer

EXPERIMENTAL

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.

Drug: Iron Isomaltoside 1000

Interventions

Iron Isomaltoside 1000 DRUG

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

Also known as: Monofer

Group A Monofer; Group B Monofer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with age ≥ 18 years
• Subjects diagnosed with IBD either in remission or active
• Hb \< 12 g/dL for women and Hb \< 13 g/dL for men
• 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
• Willingness to participate after signing informed consent

You may not qualify if:

• Patient judged by the physician to be in need of surgery due to Crohn´s disease or ulcerative colitis within the next 2 months
• Anaemia predominantly caused by factors other than IDA
• Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
• Known hypersensitivity to any excipients of iron isomaltoside 1000
• History of multiple allergies
• Decompensated liver cirrhosis and/or known chronic viral hepatitis (defined as Alanine Aminotransferase (ALAT) \> 3 times upper limit of normal)
• Acute and/or chronic infections
• Body weight \< 50 kg
• Rheumatoid arthritis with symptoms or signs of active joint inflammation
• 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)
• Blood transfusion within the previous 12 weeks
• Subjects with a history of asthma, allergic eczema, or other atopic allergy
• Planned elective surgery during the study
• Untreated Vitamin B12 or folate deficiency, defined as values below the lower reference range
• Participation in any other clinical study within 3 months prior to Screening

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Pharmacosmos A/S

Hoelbaek, Denmark

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Disease

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

DK (1)