End Stage Renal Disease on DialysisAINCT05032651
Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients
A study testing novel artificial intelligence assisted platform in people with End Stage Renal Disease on Dialysis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- novel artificial intelligence assisted platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Mar 2021to 23 Dec 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- Age older than 20 year old.
- End stage renal disease under regular hemodialysis with three times per week and duration of each session at least 4 hours
- Having at least consecutive 6 months data of both Hb and biochemical study during dialysis before enrollment and at least one Hb level within the range of 11-12 g/dl
- Having at least one prescription of ESA supplement to keep Hb within the range of 10-12 g/dl in the past 6 months before the enrollment
- Having received ESA of the same brand at least 6 months before the enrollment
Who cannot join
- Ever receiving blood transfusion in the past 12 months
- Active bleeding with blood loss more than 250cc in 3 months before the enrollment
- Active infection or malignancy
- Study subject can not follow with the study protocol
- End of Study
- The eligible subject will not be allowed to continue the study once informed consent is withdrawn or event happening meets the following criteria:
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, 807
CHEN YI PEI, 07-3121101 ext. 7901, joanna9504@gmail.com
About this study
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Later, several large-scale RCTs showing normalization of Hb in this population increased the risk of thromboembolic event, which leaded current guidelines to recommend the therapeutic goal for anemia in ESRD should be within a range (usually between 10-12 gm/dl) rather than above or below a certain level (or value). In addition to ESA dose, many factors contribute to the severity of anemia in this population, such as iron status, chronic blood loss, adequacy of dialysis, chronic inflammation, renal wasting, et al. To put all these factors together, maintaining the Hb levels within the target level is a challenge to physician. It was reported that only one third of Hb within the target at any given time. Our data showed, for those under maintenance hemodialysis and without any blood transfusion in observation period, near two third of patients' Hb level were within the target range.
Read the detailed description
For better anemia management, NKF-K/DOQI developed and published guidelines using protocol or algorithm for EPO prescription.6 Recently, artificial intelligence (AI) has been widely applied to medicine in the field of reducing human error, robotic surgical system and decision- making aid. Since then, there were several studies working on decision making programs to set up model of predicting the ESA dose needed for target Hb level. Artificial neural network (ANN) model is most commonly used for ESA dose-response prediction. However, the effectiveness of these kinds of AI is not confirmed clinically and the result not satisfactory. In other words, it is still inconclusive whether contemporary AI has any role in decision making aid when prescribing ESA dose for dialysis patient, a typical trial and error which AI supposed should be very helpful with.
Based on the mentioned above, we are going to conduct this clinical try to test the hypothesis that AI is not inferior to physician in prescribing ESA dose for hemodialysis patients to maintain hemoglobin(Hb) level to meet the target
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- novel artificial intelligence assisted platform
- Keywords
- End Stage Renal Disease, Erythropoiesis stimulating agent, Artificial intelligence assisted platform
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel artificial intelligence assisted platformDevice
Use of a novel artificial intelligence assisted platform
| Study group | Role | What they receive |
|---|---|---|
| GROUP A-AI (model) Arm Description: | Experimental | Artificial intelligence assisted platform supported system for the clinical physicians to prescribe ESA dose to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl. Receives: Device: novel artificial intelligence assisted platform |
| GROUP B-AI (model) Arm Description: | Experimental | ESA dose prescribed by clinical physicians as regular care to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl. Receives: Device: novel artificial intelligence assisted platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin (Hb) levels
Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.
Measured: 6 monthes
Secondary outcomes (2)
the target range (10-12gm/dl)
The Proportion of Participants with haemoglobin within the target range (10-12gm/dl)
Measured: 6 monthes
The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start19 Mar 2021
- Primary completion23 Dec 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomization period All eligible subjects will be randomized 1:1 by their age, gender, and HD vintage into control arm and intervention arm. After randomization, the study subject will enter the study after the nearest Hb measurement coming. Study period
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Ping-Hsun Wu, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032651
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210040
- Acronym
- AI
- Status last verified
- Jun 2021
- First submitted
- 31 Aug 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
- ClinicalTrials.gov ID
- NCT05032651
- Acronym / sponsor ID
- AI / KMUHIRB-F(I)-20210040
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- End Stage Renal Disease, Erythropoiesis stimulating agent, Artificial intelligence assisted platform
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- National Sun Yat-sen University
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 2 Sep 2021 (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.
It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Later, several large-scale RCTs showing normalization of Hb in this population increased the risk of thromboembolic event, which leaded current guidelines to recommend the therapeutic goal for anemia in ESRD should be within a range (usually between 10-12 gm/dl) rather than above or below a certain level (or value). In addition to ESA dose, many factors contribute to the severity of anemia in this population, such as iron status, chronic blood loss, adequacy of dialysis, chronic inflammation, renal wasting, et al. To put all these factors together, maintaining the Hb levels within the target level is a challenge to physician. It was reported that only one third of Hb within the target at any given time. Our data showed, for those under maintenance hemodialysis and without any blood transfusion in observation period, near two third of patients' Hb level were within the target range.
Detailed description
For better anemia management, NKF-K/DOQI developed and published guidelines using protocol or algorithm for EPO prescription.6 Recently, artificial intelligence (AI) has been widely applied to medicine in the field of reducing human error, robotic surgical system and decision- making aid. Since then, there were several studies working on decision making programs to set up model of predicting the ESA dose needed for target Hb level. Artificial neural network (ANN) model is most commonly used for ESA dose-response prediction. However, the effectiveness of these kinds of AI is not confirmed clinically and the result not satisfactory. In other words, it is still inconclusive whether contemporary AI has any role in decision making aid when prescribing ESA dose for dialysis patient, a typical trial and error which AI supposed should be very helpful with.
Based on the mentioned above, we are going to conduct this clinical try to test the hypothesis that AI is not inferior to physician in prescribing ESA dose for hemodialysis patients to maintain hemoglobin(Hb) level to meet the target
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization period All eligible subjects will be randomized 1:1 by their age, gender, and HD vintage into control arm and intervention arm. After randomization, the study subject will enter the study after the nearest Hb measurement coming. Study period
| Arm | Type | Receives |
|---|---|---|
| GROUP A-AI (model) Arm Description: | Experimental | Device: novel artificial intelligence assisted platformArtificial intelligence assisted platform supported system for the clinical physicians to prescribe ESA dose to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl. |
| GROUP B-AI (model) Arm Description: | Experimental | Device: novel artificial intelligence assisted platformESA dose prescribed by clinical physicians as regular care to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed informed consent
- Age older than 20 year old.
- End stage renal disease under regular hemodialysis with three times per week and duration of each session at least 4 hours
- Having at least consecutive 6 months data of both Hb and biochemical study during dialysis before enrollment and at least one Hb level within the range of 11-12 g/dl
- Having at least one prescription of ESA supplement to keep Hb within the range of 10-12 g/dl in the past 6 months before the enrollment
Key exclusion criteria (6 listed)
- Ever receiving blood transfusion in the past 12 months
- Active bleeding with blood loss more than 250cc in 3 months before the enrollment
- Active infection or malignancy
- Study subject can not follow with the study protocol
- End of 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 |
|---|---|---|
| novel artificial intelligence assisted platformUse of a novel artificial intelligence assisted platform | Device | GROUP A-AI (model) Arm Description:, GROUP B-AI (model) Arm Description: |
Primary outcome
hemoglobin (Hb) levels
Time frame: 6 monthes
Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.
2 secondary outcomes
the target range (10-12gm/dl)
Time frame: 6 monthes
The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Time frame: 6 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ping-Hsun Wu principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel artificial intelligence assisted platform in people with End Stage Renal Disease on Dialysis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 6 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 13 Oct 2021. 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 Taiwan. 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 Ping-Hsun Wu, PhD (07-3121101 ext. 7351, 970392KMUH@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin (Hb) levels (time frame: 6 monthes). 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 13 Oct 2021.