EUCTR2022-000894-16-NL进行中（未招募）1 期
Predicting Response to Iron Supplementation in Patients with Inflammatory Bowel Disease during Induction Therapy - PRIme
eiden University Medical Center0 个研究点目标入组 90 人开始时间: 2022年3月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
- •- 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
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