End Stage Renal DiseaseNCT04360902
Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients
A study of End Stage Renal Disease and Renal Anemia, run by Renal Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Renal Anemia, Chronic Kidney Diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
RRI
New York, New York, 10065
Manager, Renal Research Programs
About this study
Official title: Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients: A Pilot Study
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.
- Being tested
- Anemia Controller
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anemia ControllerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | No 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. |
| Intervention Group | Experimental | 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. Receives: Other: Anemia Controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 26 weeks
Secondary outcomes (2)
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)
Measured: 26 weeks
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.)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start8 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360902
- Sponsor's protocol ID
- RRI-19-003
- Status last verified
- Apr 2020
- First submitted
- 19 Dec 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuertinger DH, Wang LC, Jorg DJ, Rivera Fuentes L, Ye X, Casper S, Zhang H, Mermelstein A, Cherif A, Ho K, Raimann JG, Tisdale L, Kotanko P, Thijssen S. Effects of Individualized Anemia Therapy on Hemoglobin Stability: A Randomized Controlled Pilot Trial in Patients on Hemodialysis. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1138-1147. doi: 10.2215/CJN.0000000000000488. Epub 2024 Jun 11.
PubMed 38861324
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04360902
- Acronym / sponsor ID
- RRI-19-003
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | No 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. |
| Intervention Group | Experimental | Other: Anemia ControllerFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anemia ControllerModel 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. | Other | Intervention Group |
Primary outcome
Percentage of time spent within a Hgb target range
Time frame: 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)
2 secondary outcomes
ESA accumulated dose (mcg/Kg)
Time frame: 26 weeks
Statistical measures of Hgb variability
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 38861324Fuertinger DH, Wang LC, Jorg DJ, Rivera Fuentes L, Ye X, Casper S, Zhang H, Mermelstein A, Cherif A, Ho K, Raimann JG, Tisdale L, Kotanko P, Thijssen S. Effects of Individualized Anemia Therapy on Hemoglobin Stability: A Randomized Controlled Pilot Trial in Patients on Hemodialysis. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1138-1147. doi: 10.2215/CJN.0000000000000488. Epub 2024 Jun 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of End Stage Renal Disease and Renal Anemia, run by Renal Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manager, RRI Program (212-331-1700, sherline.pereira@rriny.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent within a Hgb target range (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.