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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT00319150
Eligibility Criteria:
Inclusion Criteria:
* written informed consent
* Adult patients \> 18 years old with current Epoetin Alpha dose \>250 units/kg/wk
* Hemoglobin \>90g/L or \<130g/L
* Patients whom a temporary fall in Hb of up to 10g/L is deemed safe
* Patients not expected to have a change in the type of Epo or route of Epo therapy for the duration of the Study period
Exclusion Criteria:
* Known iron deficiency (% saturation \<20 or ferritin \<100)
* Vit B12 or folate deficiency (levels below normal limit for centre lab)
* Known malignancy (solid organ, leukemia or multiple myeloma)
* Jehovah's witness patients/those who refuse transfusion
* Expected to die in the next 6 months
* On dialysis less than 3 months
* Temporary (not tunneled) dialysis access catheter
* Pure red cell aplasia
* High likelihood of early withdrawal or interruption of the study (eg. severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening)
* Planned major elective surgery during the study period
* Pregnancy or breast-feeding
* Women of child-bearing potential without effective contraception (abstinence, oral contraceptives, diaphragm, IUD)
* Administration of another investigational drug within 4 weeks before screening or planned during study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00319150
Study Brief:
Protocol Section:
NCT00319150