Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients

Not Applicable

• Conditions: End Stage Renal Disease; Renal Anemia; Chronic Kidney Diseases

• Registration Number: NCT04360902
• Lead Sponsor: Renal Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-19
• Study Start: 2020-01-08
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of time spent within a Hgb target range	26 weeks	The primary objective of the study is to compare the percentage of time patients will spend within the Hgb target range of 10-11 g/dL when treated with the Anemia Model Predictive Controller (intervention group) vs. when treated with the Standard of Care Algorithm (control group)

Secondary Outcome Measures

Name	Time	Method
ESA accumulated dose (mcg/Kg)	26 weeks	Compare ESA accumulated dose (mcg/Kg) between the intervention and control groups (crude as well as adjusted for attained Hgb levels)
Statistical measures of Hgb variability	26 weeks	Compare the intervention group to the control group with respect to statistical measures of Hgb variability, including gradual fluctuations in pre-dialysis Hgb levels (g/dL) with a cyclic pattern (a cycle duration from 6 to 21 weeks, and an amplitude of at least 1.5 g/dL.)

Trial Locations

Locations (1)

RRI; 🇺🇸 New York, New York, United States