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

Chronic Kidney Diseases Clinical Trial

Official title:

Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04360902
• Other study ID #: RRI-19-003
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: Renal Research Institute
• Contact: Manager, RRI Program
• Phone: 212-331-1700
• Email: sherline.pereira[@]rriny.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Diseases
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Anemia
• Renal Insufficiency, Chronic

Intervention

Other:
• Anemia Controller
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.

Locations

Country	Name	City	State
United States	RRI	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	26 weeks
Secondary	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)	26 weeks
Secondary	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.)	26 weeks