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

Primary Purpose

End Stage Renal Disease, Renal Anemia, Chronic Kidney Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anemia Controller
Sponsored by
Renal Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RRIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care Group

Intervention Group

Arm Description

Subjects in the standard of care group will continue to receive anemia management in the same way they normally do as part of their routine dialysis care. For the purposes of this study, this means the use of the clinic's established Mircera® anemia management algorithm. Participation in this study will not affect the anemia management of subjects in the control group.

For subjects randomized into the intervention group, our erythropoiesis model will be used to identify each subject's individual values for several physiological determinants of erythropoiesis based on his/her sex, body height and history of body weights, Hgb concentrations and Mircera® administrations over the preceding 150 to 180 days. For subjects in the intervention group, their current method of anemia management will be discontinued. From this point on, Mircera® dose recommendations will be generated by the Anemia Controller software based on our erythropoiesis model and each subject for the duration of their 26-week participation in this study. The Anemia Controller computes the Mircera® doses required to attain the target Hgb level of 10.5 g/dL. Controller-generated Mircera® recommendations will be communicated to the respective clinics' anemia managers on a standardized report.

Outcomes

Primary Outcome Measures

Percentage of time spent within a Hgb target range
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

ESA accumulated dose (mcg/Kg)
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
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.)

Full Information

First Posted
December 19, 2019
Last Updated
April 23, 2020
Sponsor
Renal Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04360902
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renal Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Renal Anemia, Chronic Kidney Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Subjects in the standard of care group will continue to receive anemia management in the same way they normally do as part of their routine dialysis care. For the purposes of this study, this means the use of the clinic's established Mircera® anemia management algorithm. Participation in this study will not affect the anemia management of subjects in the control group.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
For subjects randomized into the intervention group, our erythropoiesis model will be used to identify each subject's individual values for several physiological determinants of erythropoiesis based on his/her sex, body height and history of body weights, Hgb concentrations and Mircera® administrations over the preceding 150 to 180 days. For subjects in the intervention group, their current method of anemia management will be discontinued. From this point on, Mircera® dose recommendations will be generated by the Anemia Controller software based on our erythropoiesis model and each subject for the duration of their 26-week participation in this study. The Anemia Controller computes the Mircera® doses required to attain the target Hgb level of 10.5 g/dL. Controller-generated Mircera® recommendations will be communicated to the respective clinics' anemia managers on a standardized report.
Intervention Type
Other
Intervention Name(s)
Anemia Controller
Intervention Description
Model Predictive Controller software (called "Anemia Controller") that utilizes our physiology-based erythropoiesis model to provide ESA dosing recommendations in order to guide a patient's Hgb level towards a predefined target value.
Primary Outcome Measure Information:
Title
Percentage of time spent within a Hgb target range
Description
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)
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
ESA accumulated dose (mcg/Kg)
Description
Compare ESA accumulated dose (mcg/Kg) between the intervention and control groups (crude as well as adjusted for attained Hgb levels)
Time Frame
26 weeks
Title
Statistical measures of Hgb variability
Description
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.)
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager, RRI Program
Phone
212-331-1700
Email
sherline.pereira@rriny.com
Facility Information:
Facility Name
RRI
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manager, Renal Research Programs

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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