Hemodialysis ComplicationPATENCYNCT06203795
Dialysis Performance of the FX CorAL Membrane
A study testing Anticoagulation dosing, Blood sampling and Duration of the dialysis session in people with Hemodialysis Complication and Anticoagulants, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Anticoagulation remains an important issue in the setting of hemodialysis, and up till now there are some major points on which further research is needed. First, it is important to have a portfolio of the performance of different commercially available dialyzers with respect to fiber clotting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Anticoagulants
- What is being tested?
- Anticoagulation dosing, Blood sampling and Duration of the dialysis session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Oct 2023to 1 Dec 2024
- 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
- stable chronic hemodialysis patient
- well functioning vascular access
Who cannot join
- known coagulation disorder
- active inflammation
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Toxin Removal and Clotting Kinetics in Dialyzers
Anticoagulation remains an important issue in the setting of hemodialysis, and up till now there are some major points on which further research is needed. First, it is important to have a portfolio of the performance of different commercially available dialyzers with respect to fiber clotting. Second, to better estimate the impact of clotting on the overall dialysis performance, clotting kinetics during dialysis should be understood.
The aim of the present project is therefore to quantify the performance of the FX CorAL dialyzer (Fresenius Medical Care, Germany) in settings with reduced anticoagulation, and compare different performance outcomes (percent open fibers, solute removal rates) to those of other commercially available dialyzers. The different outcomes are related to the dialyzer extraction ratio and reduction ratio of small and middle molecules and albumin, the visual scoring of the dialyzer post dialysis, and the anticoagulation properties as assessed by fiber blocking in the dialyzer. Performance parameters at different time steps will allow to better understand clotting kinetics during dialysis.
Read the detailed description
The FX CorAL is a polysulfone dialyzer with improved biocompatibility due to the increased polyvinylpyrrolidone (PVP) content on its blood side surface. Herewith, protein adsorption onto the membrane is lower, decreasing initiation of inflammation and suggesting less clotting problems.
The comPERFORM study already revealed the superiority of the FX CorAL 600 dialyzer versus the polysulfone-based Xevonta Hi15 (B. Braun, Germany) and the polyethersulfone-based Elisio 150H (Nipro, Japan) with respect to the clearance of Beta-2-Microglobulin at 60 min after dialysis start. Also the clearance of the larger toxin myoglobin was found superior in the FX CorAL, and removal rates, as calculated over the 240 min post dilution hemodiafiltration sessions, were superior in the FX CorAL for both middle molecules. Furthermore, albumin sieving properties of FX CorAL changed less over time than with the competitors.
Our group previously showed that here is a correlation between myoglobin dialyzer extraction and the percentage of open dialyzer fibers as quantified using the gold standard micro Computed Tomography (CT) scanning technique. However, previous data also suggested that fiber blocking during dialysis is not a linear process, but is rather accelerated during the second half of dialysis. Nevertheless, details about the kinetics of membrane and fiber clotting are still lacking. It can be hypothesized that the membrane pores and fibers in the FX CorAL have an improved tendency to remain open during the entire dialysis session, and that this will result in improved total solute removal, especially for middle molecules. Quantification of dialyzer fiber blocking using micro-CT scanning of dialyzer cross-sections, and this preferably after different durations of dialysis sessions, should be used to test this hypothesis. By including time points for performance measurements, like Extraction Ratio, with blood sampling e.g. at 10, 30, 60 min after dialysis start on the one hand, and at 180 and 240min, it might be possible to better understand clotting kinetics.
Polysulfone and polyethersulfone membranes have previously been associated with hypersensitivity reactions attributed to the use of additives such as PVP to enhance hydrophilic properties. In the FX CorAL however, the PVP is surface-stabilized and does not elute from the inner membrane surface. The Solacea dialyzer (Nipro, Japan), manufactured with an asymmetric triacetate (ATATM) membrane without hydrophilization agents, is also showing a lower risk of hypersensitivity, less decrease in platelets, and high permeability and filtration performance, and might be seen as a competitor for the FX CorAL.
Anticoagulation needs to be well-balanced to avoid an increased risk for bleeding complications on the one hand, and clotting of the extracorporeal circuit resulting in blood loss for the patient on the other hand. A high degree of fiber clotting in the early stage of the dialysis session might also result in decreased solute removal. More biocompatible membranes, such as FX CorAL and Solacea are theoretically less prone to coagulation problems during dialysis and could be used with decreased anticoagulation dose, reducing bleeding problems whilst still maintaining patency. The Solacea dialyzer showed maintained adequacy in conditions where systemic anticoagulation is contraindicated. Up till now, no studies to explore this in the FX CorAL have been performed.
The main questions the investigators want to answer with this study are:
- How is fiber patency post dialysis in the FX CorAL versus competitors?
- Can the FX CorAL be safely and adequately used in settings with reduced anticoagulation?
- How is the time-dependent evolution of dialyzer extraction and clearance of small and middle molecules changing during the course of dialysis?
- How is the time-dependent evolution of albumin loss?
- How is the progression of membrane blockage and fiber blockage during the course of dialysis, i.e. during the last hour of a 4 hours dialysis session?
- Conditions
- Hemodialysis Complication, Anticoagulants
- Being tested
- Anticoagulation dosing, Blood sampling, Duration of the dialysis session, Choice of the hemodialyzer
- Keywords
- dialyzer fiber clotting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation dosingOther
Patients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday
Blood samplingOther
Blood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session.
Duration of the dialysis sessionOther
Patients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday
Choice of the hemodialyzerDevice
Patients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20.
| Study group | Role | What they receive |
|---|---|---|
| Hemodiafiltration with FX CorAL 800 dialyzer | Experimental | * Patients are dialyzed three consecutive dialysis sessions with an FX CorAL 800 dialyzer, starting on Saturday.
* On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
* Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin Receives: Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer |
| Hemodiafiltration with FX 800 Cordiax dialyzer | Experimental | * Patients are dialyzed three consecutive dialysis sessions with an FX 800 Cordiax dialyzer, starting on Saturday.
* On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
* Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin Receives: Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer |
| Hemodiafiltration with Solacea 19H dialyzer | Experimental | * Patients are dialyzed three consecutive dialysis sessions with a Solacea 19H dialyzer, starting on Saturday.
* On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
* Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin Receives: Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer |
| Hemodiafiltration with Xevonta Hi-20 | Experimental | * Patients are dialyzed three consecutive dialysis sessions with a Xevonta Hi-20 dialyzer, starting on Saturday.
* On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
* Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin Receives: Other: Anticoagulation dosing; Other: Blood sampling; Other: Duration of the dialysis session; Device: Choice of the hemodialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fiber patency (i.e. number of open dialyzer fibers) in FX CorAL versus the competing dialyzers
Patients are dialyzed with four different dialyzers: FX CorAL 800, FX 800 Cordiax, Solacea 19H and Xevonta 20Hi
Measured: 4 months
Calculation of dialyzer extraction in FX CorAL dialyzer in the setting of reduced anticoagulation
During the study dialysis sessions, patients only receive one quarter of their regular anticoagulation dose
Measured: 4 months
Secondary outcomes (2)
Time evolution of dialyzer extraction of uremic toxins and albumin
Blood is sampled at different time points to calculate extraction of different uremic toxins and albumin during dialysis
Measured: 4 months
Time evolution of fiber patency during dialysis
Fiber patency is determined by micro Computed Tomography (CT) scanning after the dialysis session of 4 and 3 hours, respectively. By comparing the patency for those two sessions, we will learn about the progression of fiber clotting during 3 and 4 hours dialysis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Oct 2023
- Primary completion26 Oct 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Van Biesen, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203795
- Sponsor's protocol ID
- ONZ-2023-0017 PATENCY
- Acronym
- PATENCY
- Status last verified
- Jan 2025
- First submitted
- 7 Dec 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Toxin Removal and Clotting Kinetics in Dialyzers
- ClinicalTrials.gov ID
- NCT06203795
- Acronym / sponsor ID
- PATENCY / ONZ-2023-0017 PATENCY
- Conditions
- Hemodialysis Complication, Anticoagulants
- Keywords
- dialyzer fiber clotting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Jan 2024 (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.
Anticoagulation remains an important issue in the setting of hemodialysis, and up till now there are some major points on which further research is needed. First, it is important to have a portfolio of the performance of different commercially available dialyzers with respect to fiber clotting. Second, to better estimate the impact of clotting on the overall dialysis performance, clotting kinetics during dialysis should be understood.
The aim of the present project is therefore to quantify the performance of the FX CorAL dialyzer (Fresenius Medical Care, Germany) in settings with reduced anticoagulation, and compare different performance outcomes (percent open fibers, solute removal rates) to those of other commercially available dialyzers. The different outcomes are related to the dialyzer extraction ratio and reduction ratio of small and middle molecules and albumin, the visual scoring of the dialyzer post dialysis, and the anticoagulation properties as assessed by fiber blocking in the dialyzer. Performance parameters at different time steps will allow to better understand clotting kinetics during dialysis.
Detailed description
The FX CorAL is a polysulfone dialyzer with improved biocompatibility due to the increased polyvinylpyrrolidone (PVP) content on its blood side surface. Herewith, protein adsorption onto the membrane is lower, decreasing initiation of inflammation and suggesting less clotting problems.
The comPERFORM study already revealed the superiority of the FX CorAL 600 dialyzer versus the polysulfone-based Xevonta Hi15 (B. Braun, Germany) and the polyethersulfone-based Elisio 150H (Nipro, Japan) with respect to the clearance of Beta-2-Microglobulin at 60 min after dialysis start. Also the clearance of the larger toxin myoglobin was found superior in the FX CorAL, and removal rates, as calculated over the 240 min post dilution hemodiafiltration sessions, were superior in the FX CorAL for both middle molecules. Furthermore, albumin sieving properties of FX CorAL changed less over time than with the competitors.
Our group previously showed that here is a correlation between myoglobin dialyzer extraction and the percentage of open dialyzer fibers as quantified using the gold standard micro Computed Tomography (CT) scanning technique. However, previous data also suggested that fiber blocking during dialysis is not a linear process, but is rather accelerated during the second half of dialysis. Nevertheless, details about the kinetics of membrane and fiber clotting are still lacking. It can be hypothesized that the membrane pores and fibers in the FX CorAL have an improved tendency to remain open during the entire dialysis session, and that this will result in improved total solute removal, especially for middle molecules. Quantification of dialyzer fiber blocking using micro-CT scanning of dialyzer cross-sections, and this preferably after different durations of dialysis sessions, should be used to test this hypothesis. By including time points for performance measurements, like Extraction Ratio, with blood sampling e.g. at 10, 30, 60 min after dialysis start on the one hand, and at 180 and 240min, it might be possible to better understand clotting kinetics.
Polysulfone and polyethersulfone membranes have previously been associated with hypersensitivity reactions attributed to the use of additives such as PVP to enhance hydrophilic properties. In the FX CorAL however, the PVP is surface-stabilized and does not elute from the inner membrane surface. The Solacea dialyzer (Nipro, Japan), manufactured with an asymmetric triacetate (ATATM) membrane without hydrophilization agents, is also showing a lower risk of hypersensitivity, less decrease in platelets, and high permeability and filtration performance, and might be seen as a competitor for the FX CorAL.
Anticoagulation needs to be well-balanced to avoid an increased risk for bleeding complications on the one hand, and clotting of the extracorporeal circuit resulting in blood loss for the patient on the other hand. A high degree of fiber clotting in the early stage of the dialysis session might also result in decreased solute removal. More biocompatible membranes, such as FX CorAL and Solacea are theoretically less prone to coagulation problems during dialysis and could be used with decreased anticoagulation dose, reducing bleeding problems whilst still maintaining patency. The Solacea dialyzer showed maintained adequacy in conditions where systemic anticoagulation is contraindicated. Up till now, no studies to explore this in the FX CorAL have been performed.
The main questions the investigators want to answer with this study are:
- How is fiber patency post dialysis in the FX CorAL versus competitors?
- Can the FX CorAL be safely and adequately used in settings with reduced anticoagulation?
- How is the time-dependent evolution of dialyzer extraction and clearance of small and middle molecules changing during the course of dialysis?
- How is the time-dependent evolution of albumin loss?
- How is the progression of membrane blockage and fiber blockage during the course of dialysis, i.e. during the last hour of a 4 hours dialysis session?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemodiafiltration with FX CorAL 800 dialyzer | Experimental | Other: Anticoagulation dosing, Other: Blood sampling, Other: Duration of the dialysis session, Device: Choice of the hemodialyzer* Patients are dialyzed three consecutive dialysis sessions with an FX CorAL 800 dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin |
| Hemodiafiltration with FX 800 Cordiax dialyzer | Experimental | Other: Anticoagulation dosing, Other: Blood sampling, Other: Duration of the dialysis session, Device: Choice of the hemodialyzer* Patients are dialyzed three consecutive dialysis sessions with an FX 800 Cordiax dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin |
| Hemodiafiltration with Solacea 19H dialyzer | Experimental | Other: Anticoagulation dosing, Other: Blood sampling, Other: Duration of the dialysis session, Device: Choice of the hemodialyzer* Patients are dialyzed three consecutive dialysis sessions with a Solacea 19H dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin |
| Hemodiafiltration with Xevonta Hi-20 | Experimental | Other: Anticoagulation dosing, Other: Blood sampling, Other: Duration of the dialysis session, Device: Choice of the hemodialyzer* Patients are dialyzed three consecutive dialysis sessions with a Xevonta Hi-20 dialyzer, starting on Saturday. * On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday. * Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable chronic hemodialysis patient
- well functioning vascular access
Key exclusion criteria (3 listed)
- known coagulation disorder
- active inflammation
- malignancy
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 |
|---|---|---|
| Anticoagulation dosingPatients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday | Other | Hemodiafiltration with FX 800 Cordiax dialyzer, Hemodiafiltration with FX CorAL 800 dialyzer, Hemodiafiltration with Solacea 19H dialyzer, Hemodiafiltration with Xevonta Hi-20 |
| Blood samplingBlood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session. | Other | Hemodiafiltration with FX 800 Cordiax dialyzer, Hemodiafiltration with FX CorAL 800 dialyzer, Hemodiafiltration with Solacea 19H dialyzer, Hemodiafiltration with Xevonta Hi-20 |
| Duration of the dialysis sessionPatients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday | Other | Hemodiafiltration with FX 800 Cordiax dialyzer, Hemodiafiltration with FX CorAL 800 dialyzer, Hemodiafiltration with Solacea 19H dialyzer, Hemodiafiltration with Xevonta Hi-20 |
| Choice of the hemodialyzerPatients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20. | Device | Hemodiafiltration with FX 800 Cordiax dialyzer, Hemodiafiltration with FX CorAL 800 dialyzer, Hemodiafiltration with Solacea 19H dialyzer, Hemodiafiltration with Xevonta Hi-20 |
Primary outcome
Fiber patency (i.e. number of open dialyzer fibers) in FX CorAL versus the competing dialyzers
Time frame: 4 months
Patients are dialyzed with four different dialyzers: FX CorAL 800, FX 800 Cordiax, Solacea 19H and Xevonta 20Hi
Calculation of dialyzer extraction in FX CorAL dialyzer in the setting of reduced anticoagulation
Time frame: 4 months
During the study dialysis sessions, patients only receive one quarter of their regular anticoagulation dose
2 secondary outcomes
Time evolution of dialyzer extraction of uremic toxins and albumin
Time frame: 4 months
Time evolution of fiber patency during dialysis
Time frame: 4 months
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 10 Mar 2025.
- 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.
Wim Van Biesen, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation dosing, Blood sampling and Duration of the dialysis session in people with Hemodialysis Complication and Anticoagulants, run by University Hospital, Ghent at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 Belgium. 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?
Fiber patency (i.e. number of open dialyzer fibers) in FX CorAL versus the competing dialyzers (time frame: 4 months). 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 10 Mar 2025.