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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01213680
First received: October 1, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Inflammatory Bowel Disease
Drug: Monofer (iron isomaltoside 1000)
Drug: Monofer
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Pharmakokinetic Study of Iron Isomaltoside 1000 (Monofer)Administered by 500 mg IV Injection or 1000 mg Intravenous Infusion to Patients With Inflammatory Bowel Disease (PK-IBD-02)

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Total serum iron pharmakokinetic parameters [ Time Frame: 24, 48 and72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total urine-iron pharmakokinetic parameters [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2012
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1000 mg iron isomaltoside as intravenous infusion Drug: Monofer (iron isomaltoside 1000)
1000 mg iron isomaltoside administered as a infusion over 15 minutes
Active Comparator: 500 mg iron isomaltoside 1000 as bolus injection Drug: Monofer
500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, aged more than 18 years
  2. 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)
  3. Weight above 50 kg
  4. Hb <12 g/dL (7.45 mmol/L)
  5. Transferrin saturation (TfS) <20%
  6. Life expectancy beyond 12 months by investigator's judgment
  7. Willingness to participate after informed consent -

Exclusion Criteria:

  1. Anaemia predominantly caused by other factors than iron deficiency anaemia
  2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate)
  4. Known hypersensitivity to any excipients in the investigational drug products
  5. Subjects with a history of multiple allergies
  6. Active Intestinal Tuberculosis
  7. Active intestinal amoebic infections
  8. Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) > 3 times upper limit normal)
  9. History of immunocompromise and/or history of Hepatitis B and/or C
  10. Acute infections (assessed by clinical judgment), supported by white blood cells (WBC) and C-reactive protein (CRP))
  11. Rheumatoid arthritis with symptoms or signs of active joint inflammation
  12. 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)
  13. Extensive active bleeding necessitating blood transfusion
  14. Planned elective surgery during the study
  15. Participation in any other clinical study within 3 months prior to screening
  16. Untreated B12 or folate deficiency
  17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit
  18. Erythropoietin treatment within 4 weeks prior to screening visit
  19. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example: Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213680

Sponsors and Collaborators
Pharmacosmos A/S
Investigators
Study Chair: Lars Lykke Thomsen, MD Pharmacosmos A/S
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01213680     History of Changes
Other Study ID Numbers: P-Monofer-PK-IBD-02, PK-IBD-02
Study First Received: October 1, 2010
Last Updated: November 13, 2013
Health Authority: India: DCGI

Keywords provided by Pharmacosmos A/S:
Inflammatory Bowel Disease, IBD

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014