AnemiaANEMEXNCT03214627
Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial
A study testing IV iron and Erythropoiesis-Stimulating Agent (ESA) in people with Anemia and End Stage Renal Disease, run by Vifor Fresenius Medical Care Renal Pharma at 1 site in United Kingdom.
Trial summary
Fresenius Medical Care has developed a computer software programme called the Anaemia Control Management (ACM) software to assist in the anaemia management of patients with chronic kidney disease (CKD) undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Anemia, End Stage Renal Disease
- What is being tested?
- IV iron and Erythropoiesis-Stimulating Agent (ESA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2018to 21 May 2019
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 to 90 years
- On haemodialysis for the past 18 months prior to baseline
- Treatment with IV iron sucrose during the past 6 months according to the respective Summary of Product Characteristics (SmPC)
- Treatment with epoetin beta during the past 6 months according to the respective SmPC
- Regular Hb measurements and at least 5 (standard of care, approximately monthly) Hb measurements during the past 6 months
- Ferritin measurements during the past 6 months (at least 2 measurements)
- Signed informed consent
Who cannot join
- Life expectancy <6 months
- One or more Hb measurements <8 g/dl during the control period
- Living-donor transplant scheduled within the next 6 months
- Scheduled for switch to peritoneal dialysis or home haemodialysis
- Blood transfusion during the past 9 months
- Pregnancy or breast feeding
Show all 14Show fewer
- Active infection
- Current malignancy or haematological disorder
- Previous severe hypersensitivity reaction to IV iron sucrose
- Serious allergic reactions to darbepoetin alfa or epoetin alfa/beta/zeta, respectively
- Current treatment with PEGylated erythropoietin
- Surgery in the past 6 months
- Surgery scheduled within the next 6 months
- Participation in a clinical trial in the past 7 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANEMEX UK Trial: Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial
Fresenius Medical Care has developed a computer software programme called the Anaemia Control Management (ACM) software to assist in the anaemia management of patients with chronic kidney disease (CKD) undergoing hemodialysis. This trial is designed to assess the effectiveness of this ACM software on anaemia management in routine clinical practice. However, all ultimate decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the discretion of the Investigator. The trial consists of a retrospective (historical) control period and a prospective (going forward) period. During the prospective period, the ACM will be used to assist the Investigators' decision making and will help the Investigators to administer a personalised intravenous (IV) iron and red blood cell stimulating agent (ESA) therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective period of the trial. Thus, patients can serve as their own control.
Read the detailed description
Fresenius Medical Care has developed an algorithm that uses a data-driven computational intelligence model based on an artificial neural network architecture (ACM) to generate individualised ESA dose recommendations from a history of dose and response information and specific patient demographic characteristics.
The ACM has been validated and complies with the European requirements for medical devices. The ACM was classified as a Class I medical device in accordance with Directive 93/42/EEC. A proof of concept trial was conducted in 3 NephroCare dialysis clinics (managed by Fresenius) in the Czech Republic, Portugal, and Spain. It could be shown that the introduction of ACM-guided therapy led to a significant decrease in median darbepoetin doses and to a significant increase in on-target haemoglobin (Hb) values along with a decrease in Hb fluctuation. Moreover, a retrospective trial conducted in NephroCare clinics in Portugal, suggested that ACM is able to reliably predict the long-term response to ESA and iron therapy in patients undergoing haemodialysis.
The current trial will test the applicability of the ACM outside of Fresenius clinics in a public hospital setting in the UK. Both intravenous (IV) iron and ESA doses will be recommended by the algorithm. The effectiveness of ACM-guided therapy on several anaemia outcomes will be assessed in adult patients with End Stage Renal Disease (ESRD).This trial will be conducted at 1 main unit and 5 satellite units at King's College Hospital, London, UK, in patients with ESRD who are routinely undergoing haemodialysis.
This trial is designed to assess the effectiveness of the ACM software on anaemia management in routine clinical practice. However, all ultimate decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the discretion of the Investigator.
The trial will consist of a retrospective control period and a prospective period. During the prospective period, the ACM will be used to facilitate the Investigators' decision making and will help the Investigators to administer a personalised IV iron and ESA therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective period of the trial. Thus, patients can serve as their own control.
The planned overall duration of the trial is 18 months (12 months recruitment period + 6 months until last patient last visit). The planned duration of prospective treatment for an individual patient will be 6 months. The collection of retrospective data from medical records covering a period of 6 months will take place as soon as the Informed Consent Form (ICF) is signed but at the latest at baseline.
Data will be collected at designated time Points (monthly) throughout the Trial once the ICF is signed: at the latest at baseline (collection of retrospective data), at baseline (start of prospective documentation), and for the observation time points (Month 1 to Month 6). However, examinations will follow routine clinical practice at the site according to the Investigator's decision.
- Conditions
- Anemia, End Stage Renal Disease
- Being tested
- Anemia Control Model (ACM), IV iron, Erythropoiesis-Stimulating Agent (ESA)
- Medical subject headings
- Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anemia Control Model (ACM)Device
The ACM is mainly composed of 2 sub-Systems - predictor model which, depending on the input data, forecasts the response to anaemia drug therapy for a specific patient. The predictor model is implemented as a feed-forward artificial neural network. The ACM is an algorithm that extracts the optimal policy to achieve the established clinical outcome for anaemia management using the predictor model.
IV ironDrug
Also called Venofer, iron sucrose
IV iron given monthly as required - dose determined by the ACM and as agreed by the investigator
Erythropoiesis-Stimulating Agent (ESA)Drug
Also called epoetin beta
ESA given monthly as required over 6 months - dose determined by the ACM and as agreed by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Anemia Control Model IV iron and ESA | Experimental | Anemia Control Model (ACM) algorithm to recommend monthly IV and ESA dose over a 6 month period
IV iron: given monthly as required - dosing recommendation by ACM over 6 a month period
Erythropoiesis-Stimulating Agent (ESA): given monthly as required - dosing recommendation by ACM over 6 a month period Receives: Device: Anemia Control Model (ACM); Drug: IV iron; Drug: Erythropoiesis-Stimulating Agent (ESA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of patients with haemoglobin within the target range as compared to the historical control period (non-inferiority testing)
The proportion of patients with at least 5 (standard of care, approximately monthly) Hb measurements and with 80% of these measurements within the target range of 10 to 12 g/dl from Month -6 to Month -1 will be compared with the proportion of patients with at least 5 measurements and with 80% of these measurements within target range of 10 to 12 g/dl from Month 1 to Month 6 (non-inferiority testing).
Measured: Month -6 to Month -1 compared with Month +1 to Month +6
Secondary outcomes (4)
Change in the proportion of patients with haemoglobin within the target range as compared to historical control period (superiority testing)
The proportion of patients with at least 5 (standard of care, approximately monthly) Hb measurements and with 80% of these measurements within the Hb target range of 10 to 12 g/dl from Month -6 to Month -1 will be compared with the proportion of patients with at least 5 measurements and with 80% of these measurements within target range of 10 to 12 g/dl from Month 1 to Month 6 (superiority testing).
Measured: Month -6 to Month -1 compared with Month +1 to Month +6
Change in haemoglobin fluctuations as compared to historical control period
The Hb fluctuation in patients with at least 5 (standard of care, approximately monthly) Hb measurements from Month -6 to Month -1 and from Month 1 to Month 6 as measured by Hb, Coefficient of Variation (CV), and Standard Deviation (SD) from Month -6 to Month -1 period versus Month 1 to Month 6.
Measured: Month -6 to Month -1 compared with Month +1 to Month +6
Change in cumulative ESA dose as compared to historical control period
Cumulative ESA dose from Month -6 to Month -1 versus cumulative ESA dose from Month 1 to Month 6.
Measured: Month -6 to Month -1 compared with Month +1 to Month +6
Change in cumulative IV iron dose as compared to historical control period
Cumulative IV iron dose from Month -6 to Month -1 versus cumulative IV iron dose from Month +1 to Month +6.
Measured: Month -6 to Month -1 compared with Month +1 to Month +6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start10 Dec 2018
- Primary completion21 May 2019
- Study completion21 May 2019
Why it stopped: Standard clinical practice at site caused unforeseen issues for the use of the ACM
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial will consist of a retrospective control period and a prospective period. During the prospective period, the ACM will be used to facilitate the Investigators' decision making and will help the Investigators to administer a personalised IV iron and ESA therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective (historical) period of the trial. Thus, patients can serve as their own control.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Fresenius Medical Care Deutschland GmbH
- Responsible party
- Sponsor
- Investigators
- Iain Macdougall, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214627
- Sponsor's protocol ID
- VEN-DEV-401
- Acronym
- ANEMEX
- Status last verified
- Jan 2020
- First submitted
- 5 Jul 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barbieri C, Mari F, Stopper A, Gatti E, Escandell-Montero P, Martinez-Martinez JM, Martin-Guerrero JD. A new machine learning approach for predicting the response to anemia treatment in a large cohort of End Stage Renal Disease patients undergoing dialysis. Comput Biol Med. 2015 Jun;61:56-61. doi: 10.1016/j.compbiomed.2015.03.019. Epub 2015 Mar 23.
PubMed 25864164Barbieri C, Molina M, Ponce P, Tothova M, Cattinelli I, Ion Titapiccolo J, Mari F, Amato C, Leipold F, Wehmeyer W, Stuard S, Stopper A, Canaud B. An international observational study suggests that artificial intelligence for clinical decision support optimizes anemia management in hemodialysis patients. Kidney Int. 2016 Aug;90(2):422-429. doi: 10.1016/j.kint.2016.03.036. Epub 2016 Jun 2.
PubMed 27262365Barbieri C, Bolzoni E, Mari F, Cattinelli I, Bellocchio F, Martin JD, Amato C, Stopper A, Gatti E, Macdougall IC, Stuard S, Canaud B. Performance of a Predictive Model for Long-Term Hemoglobin Response to Darbepoetin and Iron Administration in a Large Cohort of Hemodialysis Patients. PLoS One. 2016 Mar 3;11(3):e0148938. doi: 10.1371/journal.pone.0148938. eCollection 2016.
PubMed 26939055
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANEMEX UK Trial: Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial
- ClinicalTrials.gov ID
- NCT03214627
- Acronym / sponsor ID
- ANEMEX / VEN-DEV-401
- Conditions
- Anemia, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Standard clinical practice at site caused unforeseen issues for the use of the ACM
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Vifor Fresenius Medical Care Renal PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Fresenius Medical Care Deutschland GmbH
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 11 Jul 2017 (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.
Fresenius Medical Care has developed a computer software programme called the Anaemia Control Management (ACM) software to assist in the anaemia management of patients with chronic kidney disease (CKD) undergoing hemodialysis. This trial is designed to assess the effectiveness of this ACM software on anaemia management in routine clinical practice. However, all ultimate decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the discretion of the Investigator. The trial consists of a retrospective (historical) control period and a prospective (going forward) period. During the prospective period, the ACM will be used to assist the Investigators' decision making and will help the Investigators to administer a personalised intravenous (IV) iron and red blood cell stimulating agent (ESA) therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective period of the trial. Thus, patients can serve as their own control.
Detailed description
Fresenius Medical Care has developed an algorithm that uses a data-driven computational intelligence model based on an artificial neural network architecture (ACM) to generate individualised ESA dose recommendations from a history of dose and response information and specific patient demographic characteristics.
The ACM has been validated and complies with the European requirements for medical devices. The ACM was classified as a Class I medical device in accordance with Directive 93/42/EEC. A proof of concept trial was conducted in 3 NephroCare dialysis clinics (managed by Fresenius) in the Czech Republic, Portugal, and Spain. It could be shown that the introduction of ACM-guided therapy led to a significant decrease in median darbepoetin doses and to a significant increase in on-target haemoglobin (Hb) values along with a decrease in Hb fluctuation. Moreover, a retrospective trial conducted in NephroCare clinics in Portugal, suggested that ACM is able to reliably predict the long-term response to ESA and iron therapy in patients undergoing haemodialysis.
The current trial will test the applicability of the ACM outside of Fresenius clinics in a public hospital setting in the UK. Both intravenous (IV) iron and ESA doses will be recommended by the algorithm. The effectiveness of ACM-guided therapy on several anaemia outcomes will be assessed in adult patients with End Stage Renal Disease (ESRD).This trial will be conducted at 1 main unit and 5 satellite units at King's College Hospital, London, UK, in patients with ESRD who are routinely undergoing haemodialysis.
This trial is designed to assess the effectiveness of the ACM software on anaemia management in routine clinical practice. However, all ultimate decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the discretion of the Investigator.
The trial will consist of a retrospective control period and a prospective period. During the prospective period, the ACM will be used to facilitate the Investigators' decision making and will help the Investigators to administer a personalised IV iron and ESA therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective period of the trial. Thus, patients can serve as their own control.
The planned overall duration of the trial is 18 months (12 months recruitment period + 6 months until last patient last visit). The planned duration of prospective treatment for an individual patient will be 6 months. The collection of retrospective data from medical records covering a period of 6 months will take place as soon as the Informed Consent Form (ICF) is signed but at the latest at baseline.
Data will be collected at designated time Points (monthly) throughout the Trial once the ICF is signed: at the latest at baseline (collection of retrospective data), at baseline (start of prospective documentation), and for the observation time points (Month 1 to Month 6). However, examinations will follow routine clinical practice at the site according to the Investigator's decision.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial will consist of a retrospective control period and a prospective period. During the prospective period, the ACM will be used to facilitate the Investigators' decision making and will help the Investigators to administer a personalised IV iron and ESA therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective (historical) period of the trial. Thus, patients can serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Anemia Control Model IV iron and ESA | Experimental | Device: Anemia Control Model (ACM), Drug: IV iron, Drug: Erythropoiesis-Stimulating Agent (ESA)Anemia Control Model (ACM) algorithm to recommend monthly IV and ESA dose over a 6 month period IV iron: given monthly as required - dosing recommendation by ACM over 6 a month period Erythropoiesis-Stimulating Agent (ESA): given monthly as required - dosing recommendation by ACM over 6 a month period |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 19 to 90 years
- On haemodialysis for the past 18 months prior to baseline
- Treatment with IV iron sucrose during the past 6 months according to the respective Summary of Product Characteristics (SmPC)
- Treatment with epoetin beta during the past 6 months according to the respective SmPC
- Regular Hb measurements and at least 5 (standard of care, approximately monthly) Hb measurements during the past 6 months
Key exclusion criteria (14 listed)
- Life expectancy <6 months
- One or more Hb measurements <8 g/dl during the control period
- Living-donor transplant scheduled within the next 6 months
- Scheduled for switch to peritoneal dialysis or home haemodialysis
- Blood transfusion during the past 9 months
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 Control Model (ACM)The ACM is mainly composed of 2 sub-Systems - predictor model which, depending on the input data, forecasts the response to anaemia drug therapy for a specific patient. The predictor model is implemented as a feed-forward artificial neural network. The ACM is an algorithm that extracts the optimal policy to achieve the established clinical outcome for anaemia management using the predictor model. | Device | Anemia Control Model IV iron and ESA |
| IV ironAlso: Venofer, iron sucroseIV iron given monthly as required - dose determined by the ACM and as agreed by the investigator | Drug | Anemia Control Model IV iron and ESA |
| Erythropoiesis-Stimulating Agent (ESA)Also: epoetin betaESA given monthly as required over 6 months - dose determined by the ACM and as agreed by the investigator | Drug | Anemia Control Model IV iron and ESA |
Primary outcome
Change in the proportion of patients with haemoglobin within the target range as compared to the historical control period (non-inferiority testing)
Time frame: Month -6 to Month -1 compared with Month +1 to Month +6
The proportion of patients with at least 5 (standard of care, approximately monthly) Hb measurements and with 80% of these measurements within the target range of 10 to 12 g/dl from Month -6 to Month -1 will be compared with the proportion of patients with at least 5 measurements and with 80% of these measurements within target range of 10 to 12 g/dl from Month 1 to Month 6 (non-inferiority testing).
4 secondary outcomes
Change in the proportion of patients with haemoglobin within the target range as compared to historical control period (superiority testing)
Time frame: Month -6 to Month -1 compared with Month +1 to Month +6
Change in haemoglobin fluctuations as compared to historical control period
Time frame: Month -6 to Month -1 compared with Month +1 to Month +6
Change in cumulative ESA dose as compared to historical control period
Time frame: Month -6 to Month -1 compared with Month +1 to Month +6
Change in cumulative IV iron dose as compared to historical control period
Time frame: Month -6 to Month -1 compared with Month +1 to Month +6
Results and safety
The study was stopped early (reason given: Standard clinical practice at site caused unforeseen issues for the use of the ACM). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 25864164Barbieri C, Mari F, Stopper A, Gatti E, Escandell-Montero P, Martinez-Martinez JM, Martin-Guerrero JD. A new machine learning approach for predicting the response to anemia treatment in a large cohort of End Stage Renal Disease patients undergoing dialysis. Comput Biol Med. 2015 Jun;61:56-61. doi: 10.1016/j.compbiomed.2015.03.019. Epub 2015 Mar 23.
- Background: PubMed 27262365Barbieri C, Molina M, Ponce P, Tothova M, Cattinelli I, Ion Titapiccolo J, Mari F, Amato C, Leipold F, Wehmeyer W, Stuard S, Stopper A, Canaud B. An international observational study suggests that artificial intelligence for clinical decision support optimizes anemia management in hemodialysis patients. Kidney Int. 2016 Aug;90(2):422-429. doi: 10.1016/j.kint.2016.03.036. Epub 2016 Jun 2.
- Background: PubMed 26939055Barbieri C, Bolzoni E, Mari F, Cattinelli I, Bellocchio F, Martin JD, Amato C, Stopper A, Gatti E, Macdougall IC, Stuard S, Canaud B. Performance of a Predictive Model for Long-Term Hemoglobin Response to Darbepoetin and Iron Administration in a Large Cohort of Hemodialysis Patients. PLoS One. 2016 Mar 3;11(3):e0148938. doi: 10.1371/journal.pone.0148938. eCollection 2016.
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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.
Iain Macdougall principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV iron and Erythropoiesis-Stimulating Agent (ESA) in people with Anemia and End Stage Renal Disease, run by Vifor Fresenius Medical Care Renal Pharma at 1 site in United Kingdom.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 7 Jan 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 Kingdom. 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 was stopped early (reason given: Standard clinical practice at site caused unforeseen issues for the use of the ACM). 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?
Change in the proportion of patients with haemoglobin within the target range as compared to the historical control period (non-inferiority testing) (time frame: Month -6 to Month -1 compared with Month +1 to Month +6). 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 NCT03214627, which also lists 3 linked publications.
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 7 Jan 2020.