Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Anemia is the most common extraintestinal manifestation of inflammatory bowel diseases (IBD), Although most cases of anemia in IBD are due to iron deficiency, many patients with iron deficiency anemia (IDA) are not treated with iron supplementation. In addition, it has not been firmly established which iron supplementation modality provides the best results in terms of effectiveness and safety. In the present study the investigators will compare the effectiveness and efficacy of three iron supplementation modalities in IBD-associated IDA. There will be two arms of parenteral (iv) iron supplementation (ferric carboxymaltose and ferric gluconate) and one arm of oral supplementation (sucrosomial iron). Primary objective of the study is is to compare the efficacy of oral iron with that of the iv iron supplementation regimens. The primary outcome is measured as the percentage of patients responsive to iron supplementation. Response is defined by Hb normalization or by an Hb increase ≥2 g/dL by week 8 from start of therapy. As secondary objectives 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 evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo
• Collaborators: Italian Group for Inflammatory Bowel Diseases (IG-IBD); Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
• Treatments: Ferric gluconate

Criteria

Inclusion Criteria:

To be included in the trial the patient must:

• Have given written informed consent to participate

• Be aged 18 years and over

• Have a BMI >16

• Have IBD and IDA with or without inflammation

Exclusion Criteria:

• Patients with hypersensitivity to the IMPs, to other iron containing products and to sucrose or benzil alcohol will be excluded from the study.

• Pregnancy, lactation and women of childbearing potential (WOCBP) (i.e. fertile, following menarche and until becoming post-menopausal, no menses for 12 months without an alternative medical cause, unless permanently sterile) that are not willing to use highly efficient contraceptive measures according to the CTFG recommendations on contraception (Table 4);

• male patients with WOCBP partners who are unwilling to use highly efficient contraceptive measures (Table 4);

• an 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 3 or higher (estimated glomerular filtration rate <60mL/min as determined using either the CKD-EPI equation, the MDRD equation or the Cockcroft-Gault formula);

• major surgery in the previous 3 months;

• significant overt bleeding, acute severe anemia with hemodynamic instability;

• active malignancy and any hematologic disease causing anemia;

• known active infection;

• known human immunodeficiency virus HCV and HBV infections;

• evidence of tubercular (TB) infection (see section 5.2.1 for the TB screening criteria necessary to rule out active or latent TB infection).