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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT06690450
Eligibility Criteria:
Inclusion Criteria:
* Males or females over 18 years of age and able to give informed consent.
* Undergoing hemodialysis.
* If receiving epoetin α, then the dose was stable.
* Percentage serum transferrin saturation (TSAT) \<50% and serum ferritin \<800 ng/mL.
* Absence of infection, malignancy, or surgery in the month prior to study start.
* Intolerance of other iron products did not preclude participation in this study.
Exclusion Criteria:
* Known sensitivity to any component of Venofer®.
* Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
* Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
* Pregnancy or lactation.
* HIV positive by medical history or laboratory test (optional), or active hepatitis.
* Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.
* Asthma.
* Clinical evidence of gastrointestinal bleeding.
* Would probably require blood transfusion or might undergo a renal transplant during the study.
* Anticipated surgery of any kind during the study other than vascular access surgery.
* Received an investigational drug within 30 days prior to screening.
* Previously participated in another Venofer® study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06690450
Study Brief:
Protocol Section:
NCT06690450