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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02628860
Eligibility Criteria:
Inclusion Criteria:
* ≥19 years old
* anticipating PD
* preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl
* signed written informed consent
Exclusion Criteria:
* a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
* hypersensitivity to any component of the formulation
* active severe infection/inflammation
* history of transfusion, erythropoietin, \>500 mg intravenous iron administration within 4 weeks prior to screening.
* history of acquired iron overload.
* MCV \> 95µm3 or TSAT \> 35%
* patients with preoperative Hb\<7 g/dl
* pregnancy or lactation
* decreased renal function (defined as creatinine clearance \<50 L/min/1.73m2calculated by eGFR(MDRD))
* chronic liver disease or increase of liver enzymes (ALT, AST) \>5 times the upper limit of normal range
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02628860
Study Brief:
Protocol Section:
NCT02628860