Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease (IBD-02)

This study is currently recruiting participants.
Verified November 2013 by Pharmacosmos A/S
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01599702
First received: April 25, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Drug: Iron Isomaltoside 1000
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • 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. [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
    type and incidence of adverse drug reactions (ADRs)


Secondary Outcome Measures:
  • To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000 [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    obtain a target Hb (≥ 13 g/dL in men and ≥ 12g/dL in women)


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Iron Isomaltoside 1000
1500-3000mg IV depending on HB level, sex and body weight
Other Name: Monofer
Experimental: 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.
Drug: Iron Isomaltoside 1000
1500-3000mg IV depending on HB level, sex and body weight
Other Name: Monofer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599702

Locations
Denmark
Pharmacosmos A/S Recruiting
Hoelbaek, Denmark
Contact: Lars Lykke Thomsen    +4559485959      
Principal Investigator: Denmark         
Principal Investigator: Sweden         
Sponsors and Collaborators
Pharmacosmos A/S
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01599702     History of Changes
Other Study ID Numbers: P-Monofer-IBD-02
Study First Received: April 25, 2012
Last Updated: November 20, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: Den Nationale Videnskabsetiske Komité
Sweden: Medical Products Agency
Sweden:Regionala Etikprövningsnämden i Lund.
The Netherlands: Medische Ethische Toetsings Commissie
The Netherlands: CCMO (centrale commissie mensgebonden onderzoek)

Keywords provided by Pharmacosmos A/S:
IBD
IDA
Subjects
diagnosis

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 April 20, 2014