Iron deficiency anaemia due to inflammatory bowel disease MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Monofer 100mg/ml
Product Name: Monofer 100mg/ml
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Ferric derisomaltose
CAS Number: 0994-66-4
Current Sponsor code: I
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants included: 1. are = 18 years 2. have been diagnosed with IBD 3 have a hemoglobin (Hb) 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: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the incidence of hypophosphatemia (low phosphate levels in the blood) in participants with iron deficiency anaemia (low red blodd cell count caused by low iron levels) due to swelling in the gut (known as inflammatory bowel disease, IBD) treated with iron isomaltoside (Monofer®) or ferric carboxymaltose(Ferinject®) . ;Secondary Objective: To compare the effects of iron isomaltoside (Monofer®) and ferric carboxymaltose (Ferinject®) treatment in participants with iron deficiency anaemia (IDA) due to inflammatory bowel disease (IBD). Safety objectives were: • Incidence of severe hypophosphatemia (low phosphate levels in the blood) • Time with hypophosphatemia • Proportion of participants with hypophosphatemia at the last visit • Blood phosphate levels • Fractional phosphate levels in urine (wee) • Levels of intact Fibroblast Growth Factor 23 (iFGF23), C-terminal FGF23 (cFGF23) levels of vitamin D, Parathyroid Hormone (PTH) and ionized calcium • Adverse Events (AEs) and biochemical safety parameters • Clinical significant changes in vital signs (such as pulse rate and blood pressure), heart electrical activity (observed using an electrocardigram, ECG), and standard laboratory values Efficacy objectives were blood levels of: • haemoglobin (Hb) • ferritin • Transferrin Saturation (TSAT). Other objectives include;Primary end point(s): The primary endpoint is the incidence of hypophosphatemia (defined as serum phosphate < 2 mg/dL) at any time from Baseline to day 35.;Timepoint(s) of evaluation of this end point: any time between Baseline and day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): secondary safety endpoints include: a. Incidence of hypophosphatemia b. Incidence of serum phosphate < 1.0 mg/dL c. Time with hypophosphatemia (i.e. time with serum phosphate < 2.0 mg/dL) d. Proportion of participants with hypophosphatemia e. changes in serum phosphate f. Fractional phosphate urinary excretion g. Change in iFGF23, cFGF23, vitamin D (25, 1.25, 24.25), parathyroid hormone (PTH), and ionized calcium h. Type and incidence of adverse events i. Serious or severe hypersensitivity j. Clinically significant changes in vital signs, ECG and laboratory values Secondary efficacy endpoints include changes in: • Haemoglobin • Serum ferritin • Transferrin Saturation (TSAT) Secondary exploratory endpoints include changes in: 1. biochemical bone/muscle markers (serum N-terminal Propeptide of Type I Collagen (PINP), Carboxy-terminal Collagen Crosslinks (CTx), serum alkaline phosphatase (bone specific and total), and creatine kinase) 2. Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale 3. Short Form -36 quality of Life questionnaire 4. Visual Analogue Scale (VAS) for bone pain 5. grip strength (to test muscle strength) 6. upper and lower limb proximal muscle function measured by the "1 kg arm lift" test and the "30 sec chair stand" test. 7. respiratory muscles strength measured by Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) 8. disease activity status using Harvey-Bradshaw Index for Crohn’s disease or Partial Mayo Score (excluding Endoscopy Sub-score) for ulcerative colitis ;Timepoint(s) of evaluation of this end point: Secondary safety endpoints a) any time from Baseline to week 10 b) at any time from Baseline to day 35 c) end of study d) at day 35 e) from Baseline to day 1 and weeks 1, 2, 5, 6, 7, and 10 f) at day 1 and weeks 1, 2, 5, 6, 7, and 10 g) from Baseline to day 1 and weeks 1, 2, 5, 6, 7, and 10 h) after first dose till End of study i) after the first dose of treat | — |
Countries
Austria, Denmark, Germany, Sweden, United Kingdom
Contacts
Public ContactRukhsana Shaikh-Zaidi
Indagatio Clinical Limited
Outcome results
None listed