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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04360902
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Ability to give written informed consent to the study
* End-stage renal disease treated with thrice-weekly hemodialysis for at least 180 days preceding enrollment
* Receiving intradialytic Crit-Line® monitoring, with available Crit-Line® data going back at least 180 days from the date of enrollment
* Laboratory Hgb data going back at least 180 days from the date of enrollment
* On average, Hgb values available from at least 2 treatments per week (from either source, Crit-Line® or laboratory) during the past 180 days preceding enrollment
* Renal anemia treated with intravenous Mircera®, with at least 2 Mircera® dose administrations during the 150 days preceding enrollment
* On an active Mircera® anemia management algorithm order during the 180 days preceding enrollment
* Exclusively on Mircera® (no other ESAs) during the 180 days preceding enrollment
* Pattern of Hgb cycling as defined above during the 180 days preceding enrollment
Exclusion Criteria:
* Having received the maximum Mircera® dose (225 µg every other week) consistently throughout the 90 days preceding enrollment
* Hospitalization for more than 10 days during the 30 days preceding enrollment
* Severe iron deficiency (TSAT \<20%, ferritin \<100 ng/mL) in the most recent routine blood work prior to enrollment
* Any known cause of ESA resistance other than iron deficiency and inflammatory states (e.g. hematologic malignancies, hypersplenism, antibody mediated pure red cell aplasia)
* Simultaneous participation in another clinical study that may impact anemia management or the outcomes of this trial
* Inability to communicate in English or Spanish
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04360902
Study Brief:
Protocol Section:
NCT04360902