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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01599702
First Posted: May 16, 2012
Last Update Posted: April 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pharmacosmos A/S
April 25, 2012
May 16, 2012
April 29, 2015
May 2012
December 2014   (Final data collection date for primary outcome measure)
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 ]
type and incidence of adverse drug reactions (ADRs)
Same as current
Complete list of historical versions of study NCT01599702 on ClinicalTrials.gov Archive Site
To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000 [ Time Frame: up to 16 weeks ]
obtain a target Hb (≥ 13 g/dL in men and ≥ 12g/dL in women)
Same as current
Not Provided
Not Provided
 
Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease
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)
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.
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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Inflammatory Bowel Disease
Drug: Iron Isomaltoside 1000
1500-3000mg IV depending on HB level, sex and body weight
Other Name: Monofer
  • 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.
    Intervention: Drug: Iron Isomaltoside 1000
  • 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.
    Intervention: Drug: Iron Isomaltoside 1000
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
Sweden
 
NCT01599702
P-Monofer-IBD-02
No
Not Provided
Not Provided
Pharmacosmos A/S
Pharmacosmos A/S
Not Provided
Not Provided
Pharmacosmos A/S
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP