Predicting the effect of iron therapy in Inflammatory Bowel Disease

Phase 1

• Conditions: Inflammatory Bowel Disease; MedDRA version: 20.0Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.1Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2022-000894-16-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-21
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)
- Adults (=18 years of age)
- Scheduled induction therapy (any induction therapy; e.g., infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, filgotinib, tacrolimus, prednisone, etc.)
- Iron deficiency anemia (defined as ferritin <100 ug/l and hemoglobin <7.5 mmol/l for females or <8.5 mmol/l for males) or iron deficiency (defined as ferritin <100 ug/l and transferrin saturation < 20%)
- Documented informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Blood transfusion or therapy with oral and/or intravenous iron in the past eight weeks
- Documented intolerance to oral or intravenous iron
- Severe anemia (defined as hemoglobin <6.2 mmol/l for females and males)
- Documented history of liver cirrhosis, heart failure, hemoglobinopathies, autoimmune
hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary disease
(COPD)
- Documented history of recent treatment for a malignancy (excluding dermatological
malignancies such as basal cell carcinoma or squamous cell carcinoma). Patients can
be included if the treatment for malignancy has been finalized =6 months before the
inclusion date.
- Documented history of bariatric surgery or gastric/duodenal resections due to benign or
malignant pathologies
- End-stage renal disease (impaired renal function, defined as eGFR <30 ml/min/1.73m2)
- Folic acid deficiency
- Vitamin B12 deficiency
- Documented pregnancy or breastfeeding at the time of inclusion
- Documented major operation (e.g., laparotomy) less than six weeks before inclusion
- Unable to give informed consent due to inability to understand Dutch language or incapacitation (e.g., due to cognitive/psychological conditions or hospitalization in Intensive Care)
- Proton-pump inhibitor use

Study & Design

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