A study comparing the incidence of low phosphate levels in the blood (hypophosphatemia) after treatment with iron isomaltoside (Monofer®) and ferric carboxymaltose (Ferinject®) in patients with iron deficiency anaemia (low red blood cell count due to low iron levels in the blood) caused by swelling in the gut (known as inflammatory bowel disease).

Phase 1

• Conditions: Iron deficiency anaemia due to inflammatory bowel disease; MedDRA version: 20.0Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-002452-87-GB
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-11
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Participants included:
1. are = 18 years
2. have been diagnosed with IBD
3 have a hemoglobin (Hb) value < 13 g/dL
4. have a body weight = 50 kg
5. have a serum ferritin value > 100 ng/mL
6. have an eGFR (estimated Glomerular filtration rate) of = 65 mL/min/1.73 m2
7. have a serum phosphate value of > 2.5 mg/dL
8. are when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly
9. have provided written informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Exclusion criteria included:
1. Anaemia (low red blood cell count) mainly caused by factors other than inflammatory bowel disease (IDA) according to Investigator's judgment
2. Haemoglobin (Hb) = 10 g/dL and body weight < 70 kg
3. Hemochromatosis or other iron storage disorders
4. Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose
5. Previous serious hypersensitivity reactions to any intravenous (IV) iron compounds
6.Treatment with IV iron, erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, chemotherapy and/or an investigational drug within the last 30 days prior to screening
7. Planned surgery during the trial period
8.Alanine Aminotransferase (ALAT) and/or Aspartate Aminotransferase (ASAT) > 3 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis)
9. Surgery under general anaesthesia within the last 30 days prior to screening
10. Any non-viral infection within the last 30 days prior to screening
11. Alcohol or drug abuse within the past 6 months
12. Untreated hyperparathyroidism
13. Kidney transplantation
14. Conditions that interfere with the participant's ability to understand the requirements of the trial and/or presumable non-compliance
15. Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the participant’s disease management at risk or may result in the participants being unable to comply with the trial requirements
16. Pregnant or nursing women, and women of childbearing potential not using highly efficient contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified