Status:
UNKNOWN
Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients
Lead Sponsor:
Renal Research Institute
Conditions:
End Stage Renal Disease
Renal Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this randomized, controlled pilot study is to evaluate the performance of this novel Anemia Controller (vis-à-vis standard of care) for anemia management in hemodialysis patients. Since...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04360902
Start Date
January 8 2020
End Date
December 1 2021
Last Update
April 24 2020
Active Locations (1)
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1
RRI
New York, New York, United States, 10065