DialysisSMARTNCT05936021
Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model
A study testing Algorithm model-based Aranesp doses in people with Dialysis, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial summary
This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services. The purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis
- What is being tested?
- Algorithm model-based Aranesp doses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2023to 1 Jan 2025
- 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
- Males and females (≥ 18 years of age) with End Stage Kidney Disease undergoing in-center hemodialysis
- 150 days of hemoglobin readings and Aranesp doses without a hospitalization relevant to the condition of anemia
Who cannot join
- Inflammation as characterized by ferritin levels greater than 1000 ng/mL
- Patients with active cancer
- Patients with PTH greater than 1,000 pg/mL
- Active GI Bleed
- Hospitalization relevant to ESRD in last 150 days or during study
- Patients receiving Procrit rather than Aranesp.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Kidney Clinic
Murray, Utah, 84017
Dialysis Services
Murray, Utah, 84107
About this study
This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services. The purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost.
Read the detailed description
Hemoglobin cycling is an outcome of treating long-term dialysis patients for anemia using erythropoiesis-stimulating agents (ESAs), and represents a conundrum for practitioners. While patients with low hemoglobin levels suffer from anemia, high hemoglobin levels may lead to blood clots and subsequent health risks. The current protocol for ESA dosing often results in suboptimal dosing that leads to hemoglobin cycling, which can have a negative impact on patient survival. To this end, we have developed a personalized method for ESA dosing that controls anemia in dialysis patients that is similar to the commercial product sold by PhySoft. Our method, the Dialysis Anemia Treatment Model, uses a mathematical model for erythropoiesis that takes each patient's physiology into account, predicting the optimal dose of ESA for that patient to prevent hemoglobin cycling. The goal of this computer-aided approach is to reduce hemoglobin cycling and the amount of drug used by predicting optimal doses to keep the patient's hemoglobin within the desired range. This is a human subject research study to validate the model in the clinic and demonstrate that it is able to minimize hemoglobin cycling in patients and reduce the amount of ESA drug administered.
- Conditions
- Dialysis
- Being tested
- Algorithm model-based Aranesp doses, Standard of care
- Keywords
- darbepoetin, kidney, dialysis, hemoglobin cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm model-based Aranesp dosesProcedure or surgery
Patients will receive doses calculated by the algorithm instead of by the standard of care procedures. Model-based Aranesp doses will be computed at the same time that doses based on the dialysis anemia protocol are determined. The model-based doses will be administered instead of the protocol-based doses and in the same way and at the same time as the protocol-based doses would have been. The model-based dosing will be more flexible than the protocol-based dosing. Some constraints in the protocol-based dosing were created to prevent patients from achieving high Hb levels. The model-based dosing will also prevent these high Hb values but will do so by predicting a patient's Hb level into the future and then using these predictions to determine doses to reduce Hb variability and to reduce the amount of Aranesp used.
Standard of careProcedure or surgery
Current standard of care guidelines are followed for erythropoiesis-stimulating agents to control anemia in dialysis patients
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Other | All patients placed on dialysis receive standard of care Receives: Procedure: Standard of care |
| Model-based Aranesp doses | Experimental | On entering the study cohort, patients will begin receiving doses calculated by the algorithm instead of by the standard of care procedures. Model-based Aranesp doses will be computed at the same time that doses based on the dialysis anemia protocol are determined. The model-based doses will be administered instead of the protocol-based doses and in the same way and at the same time as the protocol-based doses would have been. Receives: Procedure: Algorithm model-based Aranesp doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hemoglobin cycling in dialysis patients
Reduction of hemoglobin cycling
Measured: 90 days after the intervention
Time hemoglobin levels are maintained within acceptable range
Time hemoglobin levels are maintained within acceptable range
Measured: 90 days after the intervention
Secondary outcomes (1)
Reduction in quantity of drug administered to patients
Reduction in quantity of drug administered to patients
Measured: 90 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jul 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- All patients placed on dialysis receive standard of care for a minimum of 150 days; after qualifying for the study, they enter the experimental intervention arm.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chemiti Gopal, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936021
- Sponsor's protocol ID
- SMART Study
- Acronym
- SMART
- Status last verified
- Feb 2024
- First submitted
- 27 Jun 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model
- ClinicalTrials.gov ID
- NCT05936021
- Acronym / sponsor ID
- SMART / SMART Study
- Conditions
- Dialysis
- Keywords
- darbepoetin, kidney, dialysis, hemoglobin cycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Jul 2023 (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.
This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services. The purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost.
Detailed description
Hemoglobin cycling is an outcome of treating long-term dialysis patients for anemia using erythropoiesis-stimulating agents (ESAs), and represents a conundrum for practitioners. While patients with low hemoglobin levels suffer from anemia, high hemoglobin levels may lead to blood clots and subsequent health risks. The current protocol for ESA dosing often results in suboptimal dosing that leads to hemoglobin cycling, which can have a negative impact on patient survival. To this end, we have developed a personalized method for ESA dosing that controls anemia in dialysis patients that is similar to the commercial product sold by PhySoft. Our method, the Dialysis Anemia Treatment Model, uses a mathematical model for erythropoiesis that takes each patient's physiology into account, predicting the optimal dose of ESA for that patient to prevent hemoglobin cycling. The goal of this computer-aided approach is to reduce hemoglobin cycling and the amount of drug used by predicting optimal doses to keep the patient's hemoglobin within the desired range. This is a human subject research study to validate the model in the clinic and demonstrate that it is able to minimize hemoglobin cycling in patients and reduce the amount of ESA drug administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients placed on dialysis receive standard of care for a minimum of 150 days; after qualifying for the study, they enter the experimental intervention arm.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Other | Procedure: Standard of careAll patients placed on dialysis receive standard of care |
| Model-based Aranesp doses | Experimental | Procedure: Algorithm model-based Aranesp dosesOn entering the study cohort, patients will begin receiving doses calculated by the algorithm instead of by the standard of care procedures. Model-based Aranesp doses will be computed at the same time that doses based on the dialysis anemia protocol are determined. The model-based doses will be administered instead of the protocol-based doses and in the same way and at the same time as the protocol-based doses would have been. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females (≥ 18 years of age) with End Stage Kidney Disease undergoing in-center hemodialysis
- 150 days of hemoglobin readings and Aranesp doses without a hospitalization relevant to the condition of anemia
Key exclusion criteria (6 listed)
- Inflammation as characterized by ferritin levels greater than 1000 ng/mL
- Patients with active cancer
- Patients with PTH greater than 1,000 pg/mL
- Active GI Bleed
- Hospitalization relevant to ESRD in last 150 days or during study
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 |
|---|---|---|
| Algorithm model-based Aranesp dosesPatients will receive doses calculated by the algorithm instead of by the standard of care procedures. Model-based Aranesp doses will be computed at the same time that doses based on the dialysis anemia protocol are determined. The model-based doses will be administered instead of the protocol-based doses and in the same way and at the same time as the protocol-based doses would have been. The model-based dosing will be more flexible than the protocol-based dosing. Some constraints in the protocol-based dosing were created to prevent patients from achieving high Hb levels. The model-based dosing will also prevent these high Hb values but will do so by predicting a patient's Hb level into the future and then using these predictions to determine doses to reduce Hb variability and to reduce the amount of Aranesp used. | Procedure or surgery | Model-based Aranesp doses |
| Standard of careCurrent standard of care guidelines are followed for erythropoiesis-stimulating agents to control anemia in dialysis patients | Procedure or surgery | Standard of care |
Primary outcome
Reduction of hemoglobin cycling in dialysis patients
Time frame: 90 days after the intervention
Reduction of hemoglobin cycling
Time hemoglobin levels are maintained within acceptable range
Time frame: 90 days after the intervention
Time hemoglobin levels are maintained within acceptable range
1 secondary outcome
Reduction in quantity of drug administered to patients
Time frame: 90 days after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Chemiti Gopal, MD principal investigator
Intermountain Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm model-based Aranesp doses in people with Dialysis, run by Intermountain Health Care, Inc. at 2 sites 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 2 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of hemoglobin cycling in dialysis patients (time frame: 90 days after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.