Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT01864161
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Signed written informed consent;
* Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);
* hemoglobin ≤ 12g/dL;
* Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;
* If erythropoiesis stimulating agents (ESA) therapy, stable dose for at least three months;
Exclusion Criteria:
* Infectious diseases;
* bleeding in the preceding six months;
* History of malignancy tumor in the last 3 years;
* Anemia case different from that resulting from CKD;
* vitamin B12 and folate deficiency;
* Surgery of any kind in the last three months;
* systemic haematological disease;
* Blood Transfusions, therapy with intravenous or oral iron in the last three months;
* Severe liver disease / test positive for hepatitis C virus (HCV) and hepatitis B virus (HBV);
* Abuse of alcohol and drugs in the preceding six months;
* immunosuppressive therapy ;
* Significant weight loss;
* Pregnancy or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01864161
Study Brief:
Protocol Section:
NCT01864161