Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

NCT01213680 | Completed Phase 1

• 2 other identifiers: P-Monofer-PK-IBD-02PK-IBD-02
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease, IBD

Outcome Measures

Primary Outcomes (1)

• Total serum iron pharmakokinetic parameters

  24, 48 and72 hours

Secondary Outcomes (1)

• Total urine-iron pharmakokinetic parameters

  24, 48 and 72 hours

Study Arms (2)

1000 mg iron isomaltoside as intravenous infusion

ACTIVE COMPARATOR

Drug: Monofer (iron isomaltoside 1000)

500 mg iron isomaltoside 1000 as bolus injection

ACTIVE COMPARATOR

Drug: Monofer

Interventions

Monofer (iron isomaltoside 1000) DRUG

1000 mg iron isomaltoside administered as a infusion over 15 minutes

1000 mg iron isomaltoside as intravenous infusion

Monofer DRUG

500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes

500 mg iron isomaltoside 1000 as bolus injection

Eligibility Criteria

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

You may qualify if:

• Men and women, aged more than 18 years
• Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis)
• Weight above 50 kg
• Hb \<12 g/dL (7.45 mmol/L)
• Transferrin saturation (TfS) \<20%
• Life expectancy beyond 12 months by investigator's judgment
• Willingness to participate after informed consent -

You may not qualify if:

• Anaemia predominantly caused by other factors than iron deficiency anaemia
• Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
• Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate)
• Known hypersensitivity to any excipients in the investigational drug products
• Subjects with a history of multiple allergies
• Active Intestinal Tuberculosis
• Active intestinal amoebic infections
• Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) \> 3 times upper limit normal)
• History of immunocompromise and/or history of Hepatitis B and/or C
• Acute infections (assessed by clinical judgment), supported by white blood cells (WBC) and C-reactive protein (CRP))
• Rheumatoid arthritis with symptoms or signs of active joint inflammation
• Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches)
• Extensive active bleeding necessitating blood transfusion
• Planned elective surgery during the study
• Participation in any other clinical study within 3 months prior to screening

Sponsors & Collaborators

• Pharmacosmos A/S: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Lars Lykke Thomsen, MD

  Pharmacosmos A/S

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2013

Record last verified: 2013-11