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Model Predictive Controller

Intervention Group for Chronic Kidney Disease

N/A
Waitlist Available
Research Sponsored by Renal Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

Study Summary

This trial is testing a new Anemia Controller against the current standard of care for anemia management in hemodialysis patients. The Anemia Controller is designed to keep patients at a pre-defined Hgb target level, so the target population for this study are patients whose Hgb levels are currently not well-controlled.

Eligible Conditions
  • Chronic Kidney Disease
  • Kidney Anemia
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of time spent within a Hgb target range
Secondary outcome measures
ESA accumulated dose (mcg/Kg)
Statistical measures of Hgb variability

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Standard of Care GroupActive Control1 Intervention
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.

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Who is running the clinical trial?

Renal Research InstituteLead Sponsor
34 Previous Clinical Trials
79,354 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients
2020. "Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04360902.
All > Autoimmune Hemolytic Anemia
~11 spots leftby May 2025
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