Clinical trial NCT04360902: Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients
Official title: Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Renal Anemia
Chronic Kidney Diseases
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 the Anemia Controller is designed to bring patients to a pre-defined Hgb target level and keep them there, the target population for this study are patients whose Hgb levels are currently not well-controlled (rather than patients who are already relatively stable within the Hgb target range under a standard anemia management algorithm). Specifically, therefore, the target population for this clinical study are chronic hemodialysis patients who are exhibiting Hgb cycling.


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

Primary outcomes:
measure: Percentage of time spent within a Hgb target range
timeFrame: 26 weeks
Secondary outcomes:
measure: ESA accumulated dose (mcg/Kg)
timeFrame: 26 weeks
measure: Statistical measures of Hgb variability
timeFrame: 26 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: RRI
state: New York
Study officials:
References: