Anemia in children with Inflammatory Bowel Disease (IBD)
Conditions
Interventions
Trade Name: Ferinject
Product Name: ferinject
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the plac
Sponsors
Atrium Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children attending a pediatrician/ pediatric gastro- enterologist 2. Suffering from CD/CU (diagnosed according to Porto criteria) 3. Anemia according to WHO criteria 4. Written informed consent of parent with authority. 5. Children aged 0 – 18 years 6. 6.Ability to understand and speak Dutch language Are the trial subjects under 18? yes Number of subjects for this age range: 32 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Allergic reactions to intravenous iron therapy 2. Previous administration of IV iron therapy 3. Known hemochromatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of this multi center, randomized controlled trial is to determine effectiveness of IV administration of ferric carboxymaltose to patients with CU/CD with regard to improvement of laboratory markers of the iron metabolism and improvement of quality of life compared to oral iron supplementation. Primary objective: the elevation of hemoglobin with 1.25 mmol/l after administration of IV ferric carboxymaltose therapy. Secondary objectives: QoL measurements, measurement of clinical and biochemical disease activity according to PCDAI and PUCAI scoring systems (see 1.5.4), laboratory markers to measure replenishment of iron stores, side effects on liver functioning and electrolyte homeostasis.;Secondary Objective: Secondary objectives: QoL measurements, measurement of clinical and biochemical disease activity according to PCDAI and PUCAI scoring systems (see 1.5.4), laboratory markers to measure replenishment of iron stores, side effects on liver functioning and electrolyte homeostasis.;Primary end point(s): Primary outcome variables in the study are: • Elevation of Hb with 1.25 mmol/L three months after administration of IV ferric carboxymaltose therapy in comparison to the Hb level at inclusion in the study;Timepoint(s) of evaluation of this end point: After 4 weeks, after 3 and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome variables in the study are: • QoL will be measured at baseline (T=0), 4 weeks (T=1), 3 months (T=2) and 6 months (T=3) after the start of the intervention. • Clinical disease activity according to PCDAI and PUCAI scoring system at T=0, T=2, T=3 • Laboratory markers for: o Effectiveness of IV iron therapy in replenishment of iron stores: Ht, cell indices, thrombocytes, MCV, ferritin, TIBC, serum iron level, transferrin saturation, reticulocyte count, sTfR, CRP, transferrin receptors to log ferritin(TfR-F ratio), transferine/log ferritine ratio, hepcidin o Side effects of IV iron therapy on liver: AST, ALT, AF, total protein, albumin o Side effects on electrolyte homeostasis: phosphate;Timepoint(s) of evaluation of this end point: After 4 weeks, after 3 and 6 months | — |
Countries
Netherlands
Contacts
Public ContactNanja Bevers
Atrium Medical Centre
Outcome results
None listed