End Stage Renal DiseaseNCT04185519
A Model of Computer-assisted Prescription of Erythropoiesis-stimulating Agents (ESA) in Patients Under Hemodialysis
A study testing AI (model) in people with End Stage Renal Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- AI (model)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jul 2019to 30 Jul 2020
- 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
- Main inclusion criteria:
- 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
- Main exclusion criteria:
- Ever receiving blood transfusion in the past 12 months
- Active bleeding with blood loss more than250cc in 3 months before the enrollment
- Active infection or malignancy
- Study subject can not follow with the study protocol 3. 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The eligible subject will not be allowed to continue the study once informed consent is withdrawn or event happening meets the following criteria:
- Taking extra ESAs, Androgens and iron-chelating agents
- Undergoing surgery with massive haemorrhage, or blood transfusion
- Receiving systemic chemotherapy or radiotherapy or immunosuppressive therapies.
- The end of study will be 6 months later after the randomization of last study subject or failed prescription rate higher than 5%, which comes earlier.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, TW, 807
About this study
This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl.
Read the detailed description
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.
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
- Being tested
- AI (model)
- 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.
AI (model)Device
The process of the experiment (brief describe) This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl. A blind check by another physician for the prescriptions from both physician and AI (model) is arranged for safety purpose. Another physician will fail the prescription if the prescribed ESA dose, by his/her experience, will lead the participant's hemoglobin outside the range between 9 and 13 g/dl. Once the failed rate by AI is higher than the physician is 5%, , the study will be terminated. There will be three periods, namely ry 3 months.
| Study group | Role | What they receive |
|---|---|---|
| AI (model) | Experimental | This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl. A blind check by another physician for the prescriptions from both physician and AI (model) is arranged for safety purpose. Receives: Device: AI (model) |
| DR1 | No intervention | Another physician will fail the prescription if the prescribed ESA dose, by his/her experience, will lead the participant's hemoglobin outside the range between 9 and 13 g/dl. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin (Hb) levels
Primary analysis will be conducted after database lock and unblinded. For hemoglobin (Hb) levels, the logistic regression model will include treatment (AI vs. conventional), center, and treatment-by-center interaction as factors, and mean change of the hemoglobin (Hb) levels from 11g/dl during the evaluation period as dependent variables, model-based point estimates and 95% confidence interval (CI) for the treatment effects will be calculated to test the primary outcome
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 posted4 Dec 2019
- Study start24 Jul 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Informed consent must be signed before any procedures related to the study for any participant. The subject who meets the inclusion and exclusion criteria will be enrolled and a total of 126 subjects needed to have the power to test the hypothesis. In addition to the Hb levels and EAS doses, all HD-related bio information data in 12 consecutive months before enrollment will be uploaded into the model for further ESA dose prediction. Before randomization, the study subject will continue to receive the ESA by the prescription from the physician. 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185519
- Sponsor's protocol ID
- KMUHIRB-F(I)-20190094
- Status last verified
- Sep 2019
- First submitted
- 17 Nov 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim LM, Lin MY, Hsu C, Ku C, Chen YP, Kang Y, Chiu YW. Computer-assisted prescription of erythropoiesis-stimulating agents in patients undergoing maintenance hemodialysis: a randomized control trial for artificial intelligence model selection. JAMIA Open. 2025 Mar 27;8(2):ooaf020. doi: 10.1093/jamiaopen/ooaf020. eCollection 2025 Apr.
PubMed 40161549
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model of Computer-assisted Prescription of Erythropoiesis-stimulating Agents (ESA) in Patients Under Hemodialysis
- ClinicalTrials.gov ID
- NCT04185519
- Acronym / sponsor ID
- KMUHIRB-F(I)-20190094
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 4 Dec 2019 (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 randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl.
Detailed description
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.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Informed consent must be signed before any procedures related to the study for any participant. The subject who meets the inclusion and exclusion criteria will be enrolled and a total of 126 subjects needed to have the power to test the hypothesis. In addition to the Hb levels and EAS doses, all HD-related bio information data in 12 consecutive months before enrollment will be uploaded into the model for further ESA dose prediction. Before randomization, the study subject will continue to receive the ESA by the prescription from the physician. 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.
| Arm | Type | Receives |
|---|---|---|
| AI (model) | Experimental | Device: AI (model)This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl. A blind check by another physician for the prescriptions from both physician and AI (model) is arranged for safety purpose. |
| DR1 | No intervention | –Another physician will fail the prescription if the prescribed ESA dose, by his/her experience, will lead the participant's hemoglobin outside the range between 9 and 13 g/dl. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AI (model)The process of the experiment (brief describe) This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl. A blind check by another physician for the prescriptions from both physician and AI (model) is arranged for safety purpose. Another physician will fail the prescription if the prescribed ESA dose, by his/her experience, will lead the participant's hemoglobin outside the range between 9 and 13 g/dl. Once the failed rate by AI is higher than the physician is 5%, , the study will be terminated. There will be three periods, namely ry 3 months. | Device | AI (model) |
Primary outcome
hemoglobin (Hb) levels
Time frame: 6 monthes
Primary analysis will be conducted after database lock and unblinded. For hemoglobin (Hb) levels, the logistic regression model will include treatment (AI vs. conventional), center, and treatment-by-center interaction as factors, and mean change of the hemoglobin (Hb) levels from 11g/dl during the evaluation period as dependent variables, model-based point estimates and 95% confidence interval (CI) for the treatment effects will be calculated to test the primary outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 40161549Lim LM, Lin MY, Hsu C, Ku C, Chen YP, Kang Y, Chiu YW. Computer-assisted prescription of erythropoiesis-stimulating agents in patients undergoing maintenance hemodialysis: a randomized control trial for artificial intelligence model selection. JAMIA Open. 2025 Mar 27;8(2):ooaf020. doi: 10.1093/jamiaopen/ooaf020. eCollection 2025 Apr.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI (model) in people with End Stage Renal Disease, 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?
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: finished, as of the sponsor's last update on 1 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
On the ClinicalTrials.gov record for NCT04185519, 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 1 Sep 2021.