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 2012 by Pharmacosmos A/S
Sponsor:
Pharmacosmos A/S
Collaborators:
Max Neeman International
Pharma Consulting Group AB
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01599702
First received: April 25, 2012
Last updated: November 22, 2012
Last verified: November 2012
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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 |
|---|---|
|
Inflammatory Bowel Disease |
Drug: Iron Isomaltoside 1000 |
| 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: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (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 as a single infusion. 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 2,000 mg and 8 weeks later a second administration of 500 mg or 1,000 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:
- 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
Exclusion Criteria:
- 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
- IV iron treatment within 8 weeks prior to Screening
- Oral iron treatment within 1 week prior to Screening
- Erythropoiesis Stimulating Agent (ESA) treatment within 8 weeks prior to Screening
- 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 | |
| Denmark | Recruiting |
| Denmark, Denmark | |
| Contact: Thomsen 4559485959 llt@pharmacosmos.com | |
| Principal Investigator: Thomsen | |
| Sweden | |
| Sweden | Recruiting |
| Sweden, Sweden | |
| Contact: Thomsen 4559485959 llt@pharmacosmos.com | |
| Principal Investigator: Thomsen | |
Sponsors and Collaborators
Pharmacosmos A/S
Max Neeman International
Pharma Consulting Group AB
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 22, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency Denmark: Den Nationale Videnskabsetiske Komité Sweden: Medical Products Agency Sweden:Regionala Etikprövningsnämden i Lund. |
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 May 16, 2013