Iron therapy in the treatment of anemia in inflammatory bowel disease

Phase 1

• Conditions: Anemia in inflammatory bowel disease; MedDRA version: 20.1Level: HLTClassification code 10017921Term: Gastrointestinal inflammatory disorders NECSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001772-30-IT
• Lead Sponsor: FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•Have given written informed consent to participate
•Be aged 18 years and over
•Have IBD and IDA with or without inflammation
•Have a BMI >16

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

•Patients with hypersensitivity to the IMPs, to other iron containing products and to sucrose or benzil alcohol
•Pregnancy, lactation and women of childbearing potential (WOCBP) not willing to use highly efficient contraceptive measures
•history of erythropoietin treatment within 4 weeks prior to recruitment;
•alcohol abuse, liver cirrhosis, active hepatitis or signs of liver disease with a Child-Pugh class B or C;
•chronic renal failure stage 4 or higher
•major surgery in the previous 3 months;
•significant overt bleeding,
•acute severe anemia with hemodynamic instability;
•active malignancy
•any hematologic disease causing anemia;
•known active infection;
•known human immunodeficiency virus, HCV and HBV infections;
•evidence of tubercular (TB) infection

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary endpoint of the trial is to compare the efficacy of oral iron with that of the iv iron supplementation regimens in the treatment of IDA in IBD. The primary comparison of interest regards the 2 combined iv regimens vs. the oral iron supplementation. Non inferiority of the oral regimen is hypothesized.;Secondary Objective: To evaluate the influence of anemia and its treatment on fatigue, quality of life, hospitalizations, additional outpatient visits, number of endoscopic examinations; further treatments and relative side effects will be determined and these data will be used for a cost-effectiveness evaluation of different iron supplementation regimens;Primary end point(s): Proportion of patients responsive to iron supplementation. Response is defined by Hb normalization or by an Hb increase =2 g/dL by week 8. Normalization of Hb occurs with Hb values =12 g/dL in females or =13 g/dL in males.;Timepoint(s) of evaluation of this end point: week 8

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -The proportion of responsive patients (defined according to criteria reported for the primary endpoint) plus patients with an Hb increase =1 g/dL at weeks 4, 8, 12 and 24; changes in Hb levels at the reported time points will be evaluated. <br>- Safety of the three iron supplementation treatments <br>- Costs-efficacy ratio - impact on quality of life<br>;Timepoint(s) of evaluation of this end point: Week 4, 8, 12, 24