Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Prospective, Single-blinded, Controlled Study to Investigate the Efficacy and Safety of a Standardised Maintenance Dosage Regimen of Intravenous Ferric Carboxymaltose (FERINJECT®) Versus Placebo in Patients With Iron Deficiency Caused by Inflammatory Bowel Disease
Brief Summary: The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.


Options:
A: Inclusion Criteria:

* 18 years of age or older;
* Outpatients followed at a HF Clinic in a tertiary care Hospital with clinical diagnosis of HF for at least 3 months before study entry;
* NYHA functional class II to IV, who are able to perform ergospirometry;
* Documentation of LVEF \< 40% within the last 6 months;
* Adequate baseline therapy for HF based on patient's functional class (β-blockers, ACE inhibitors irrespective of functional class except if contra-indications, digoxin, spironolactone if NYHA class III or IV);
* Stable baseline HF therapy with same doses of medications and no intent to increase doses for the following 3 months;
* Hemoglobin ≤ 12 g/dl and \> 9 g/dl;
* Transferrin saturation \< 20% and ferritin \< 500 µg/L;
* Ability to provide written informed consent.

Exclusion Criteria:

* Any clinically overt bleeding: gastrointestinal bleeding, hypermenorrhea, history of peptic ulcer without evidence of healing or inflammatory intestinal diseases;
* Uncorrected hypothyroidism;
* Other inflammatory, neoplastic or infectious disease;
* Serum creatinine \> 1,5 mg/dl;
* Previous intolerance to oral elemental iron compounds;
* HF due to alcoholic cardiomyopathy, current regular drinker of alcoholic beverages or HF due to peripartum cardiomyopathy;
* Recent admission for decompensated HF (last month)
* Recent myocardial revascularization procedures (last 3 months);
* Recent ACS, stroke or TIA (last 3 months);
* Active or metastatic neoplastic disease with life expectancy of less than a year;
* Patients in heart transplantation list;
* Patients that had participated in any other clinical trial or study within the last month;
* Pregnant or lactating women;
* Pre-menopausal women that are not using any effective method of contraception;
* Patients using prohibited medications or that have not yet accomplished the wash-out period;
* Patients currently participating in cardiovascular rehabilitation programs.
B: Inclusion Criteria:

* Patients 65 years and older.
* Osteoporotic hip fracture which require surgical intervention
* Haemoglobin levels between 90-120 g/L
* Signed informed consent form

Exclusion Criteria:

* Bone marrow diseases which could interfere in the erythropoietic process (acute or chronic myelodysplastic syndromes or myeloproliferative diseases, and/or infiltration of the bone marrow due to solid or lymphatic neoplasms)
* Blood coagulation diseases or currently treated with oral anticoagulants and/or heparin at therapeutic doses.
* Documented allergy and/or previous intolerance and/or contraindication of erythropoietin use and/or intravenous iron.
* Patients with rheumatoid arthritis and/or another demonstrated origin of inflammatory anemia and/or not controlled arterial hypertension.
C: Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. Participants with IDA defined as having:

   1. Hemoglobin \<10.0 g/deciliter (dL)
   2. Transferrin saturation \<20%
3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to IV iron
2. Allergy to two or more classes of drugs
3. Participants on dialysis or with an estimated glomerular filtration rate \<30 mL/minute/1.73 m\^2
4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin \>600 nanograms/mL
D: Inclusion Criteria

Non-anaemic patients treated in the FERGI-CORRECTION study (Hb ≥12 g/dL female, ≥13 g/dL male), independent of ferritin value.

Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.

Exclusion Criteria:

Chronic alcohol abuse (alcohol consumption \>20 g/day).

Presence of portal hypertension with oesophageal varices. History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.

Known hypersensitivity to FERINJECT®.

History of acquired iron overload.

Myelodysplastic syndrome.

Pregnancy or lactation.

Known active infection, clinically significant overt bleeding, active malignancy. Known chronic renal failure.

Surgery with relevant blood loss (defined as Hb drop \<2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.

Chronic liver disease or increase of liver enzymes (alanine aminotransferase (\[ALT\], aspartate aminotransferase \[AST\]) \>3 times the upper limit of normal range.

Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Inability to fully comprehend and/or perform study procedures in the investigator's opinion.

Participation in any other interventional study (except correction study) within 1 month prior to screening.

Body weight \<35 kg.

Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.

Answer: D