Chronic Kidney DiseasesNUDGE-CKDNCT06300086
Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease
A study testing Electronically delivered nudging letters to patients with CKD and Electronically delivered nudging letter to associated GPs of patients with CKD in people with Chronic Kidney Diseases and Behavior and Behavior Mechanisms, run by Tor Biering-Sørensen at 1 site in Denmark.
Trial summary
Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Behavior and Behavior Mechanisms
- What is being tested?
- Electronically delivered nudging letters to patients with CKD and Electronically delivered nudging letter to associated GPs of patients with CKD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,388 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Aug 2024to 19 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age +18 years
- Diagnosis of CKD defined as at least one hospital encounter with the following ICD-10 codes in the primary diagnostic positions within ≤ 5 years: N18- N19, I12, E102, E112, E132, E142.
Who cannot join
- For patient-level intervention comparisons:
- 1) Exemption from the official, mandatory Danish electronic mailbox system.
- For general practice-level intervention comparisons:
- Individuals on a patient list of general practice clinics run by Danish administrative Regions.
- Individuals not on a patient list of a general practice.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Capital Region, 2900
About this study
Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.
This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters.
Read the detailed description
The study is a prospective, 2x2 factorial, registry-based, randomized, open-label implementation trial. The study population will consist of Danish adults diagnosed with CKD. Participants will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10).
The primary objective of this study is to investigate the effects of electronically sent nudging letters delivered directly to (1) patients with CKD and, separately, (2) electronically sent nudge letters delivered to GPs of the included CKD patients on the primary outcome of use of GDMT defined as at least one prescription of RASi or SGLT2i 6 months after intervention delivery in patients with CKD.
Patients with CKD will be randomized (1:1) to either a control arm (no digital nudge letters sent to the patient) or an intervention arm (a digital nudge letter). GPs of the enrolled patients with CKD will be randomized (1:1) to a control arm (no digital nudge letters sent to the GP) or an intervention arm (a digital nudge letter). The letters will inform the recipients about the importance of GDMT in CKD and that updated Danish guidelines for treating CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines.
The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries except for information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.
This study will coincide with the release of the updated clinical guidelines on the treatment of CKD by the Danish Society of Nephrology.
- Being tested
- Electronically delivered nudging letters to patients with CKD, Electronically delivered nudging letter to associated GPs of patients with CKD
- Keywords
- Chronic Kidney Disease, Nudging, Behavioral Science, Guideline-directed medical therapy
- Medical subject headings
- Renal Insufficiency, Chronic, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronically delivered nudging letters to patients with CKDBehavioural
Also called Patient letters
Patients in the active arm will receive a digital nudge letter as part of the study. The nudge letter will be delivered at baseline. Letters will be delivered through the official, mandatory Danish electronic letter system.
The control arm will consist of patients with CKD randomized to not receive digital nudge letters (usual care).
Electronically delivered nudging letter to associated GPs of patients with CKDBehavioural
Also called GP letter
The associated GPs of the patients in the active arm will receive one digital nudge letter as part of the study. The nudge letter will be delivered at baseline. The letters will be delivered through the official, mandatory Danish electronic letter system.
The control arm will consist of patients with CKD whose associated GP was randomized to not receive a digital nudge letter (usual care).
| Study group | Role | What they receive |
|---|---|---|
| Patient letters + no GP letter. | Experimental | Patients with CKD will receive digital nudge letters, but their associated GPs will not receive a digital nudge letter.
The letters will inform patients with CKD of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. Receives: Behavioral: Electronically delivered nudging letters to patients with CKD |
| Patient letters + GP letter. | Experimental | Patients with CKD and their associated GPs will receive digital nudge letters.
The letters will inform the recipients of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines. Receives: Behavioral: Electronically delivered nudging letters to patients with CKD; Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKD |
| No patient letters + GP letter | Experimental | Patients with CKD will not receive digital nudge letters, but their associated GPs will receive a digital nudge letter.
The letter will inform the GPs of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter will also include the definition of CKD and a summary of the guidelines. Receives: Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKD |
| No patient letters + no GP letter | No intervention | Neither patients with CKD nor their associated GPs will receive digital nudge letters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
Measured: within 6 months
Secondary outcomes (8)
Number of participants with any prescription of renin-angiotensin system inhibition
Measured: within 6 months
Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors
Measured: within 6 months
Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
Measured: within 6 months
Number of participants with a new prescription of renin-angiotensin system inhibition
Measured: within 6 months
Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors
Measured: within 6 months
Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
Measured: within 6 months
Time from intervention delivery to a new prescription of renin-angiotensin system inhibition
Measured: within 6 months
Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start19 Aug 2024
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design
- Masking
- None (open label)
- Enrolment
- 28,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Tor Biering-Sørensen, MD, MSc, MPH, PhD, Principal investigator, Study Principal Investigator Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300086
- Sponsor's protocol ID
- NUDGE-CKD
- Acronym
- NUDGE-CKD
- Status last verified
- Sep 2025
- First submitted
- 16 Feb 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
Publications
Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall HGC, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. A Nationwide Factorial Randomized Trial of Electronic Nudges to Patients With Chronic Kidney Disease and Their General Practices for Increasing Guideline-Directed Medical Therapy: The NUDGE-CKD Trial. Circulation. 2025 Aug 12;152(6):369-383. doi: 10.1161/CIRCULATIONAHA.125.075403. Epub 2025 Jun 7.
PubMed 40481660Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall H, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. Rationale and design of NUDGE-CKD: A nationwide randomized factorial trial of electronic nudges for increasing guideline-directed medical therapy in chronic kidney disease. Am Heart J. 2025 Sep;287:61-78. doi: 10.1016/j.ahj.2025.03.015. Epub 2025 Mar 31.
PubMed 40174694
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06300086
- Acronym / sponsor ID
- NUDGE-CKD / NUDGE-CKD
- Keywords
- Chronic Kidney Disease, Nudging, Behavioral Science, Guideline-directed medical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28,388 participants (actual)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 8 Mar 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.
Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.
This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters.
Detailed description
The study is a prospective, 2x2 factorial, registry-based, randomized, open-label implementation trial. The study population will consist of Danish adults diagnosed with CKD. Participants will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10).
The primary objective of this study is to investigate the effects of electronically sent nudging letters delivered directly to (1) patients with CKD and, separately, (2) electronically sent nudge letters delivered to GPs of the included CKD patients on the primary outcome of use of GDMT defined as at least one prescription of RASi or SGLT2i 6 months after intervention delivery in patients with CKD.
Patients with CKD will be randomized (1:1) to either a control arm (no digital nudge letters sent to the patient) or an intervention arm (a digital nudge letter). GPs of the enrolled patients with CKD will be randomized (1:1) to a control arm (no digital nudge letters sent to the GP) or an intervention arm (a digital nudge letter). The letters will inform the recipients about the importance of GDMT in CKD and that updated Danish guidelines for treating CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines.
The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries except for information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.
This study will coincide with the release of the updated clinical guidelines on the treatment of CKD by the Danish Society of Nephrology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Patient letters + no GP letter. | Experimental | Behavioral: Electronically delivered nudging letters to patients with CKDPatients with CKD will receive digital nudge letters, but their associated GPs will not receive a digital nudge letter. The letters will inform patients with CKD of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. |
| Patient letters + GP letter. | Experimental | Behavioral: Electronically delivered nudging letters to patients with CKD, Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKDPatients with CKD and their associated GPs will receive digital nudge letters. The letters will inform the recipients of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines. |
| No patient letters + GP letter | Experimental | Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKDPatients with CKD will not receive digital nudge letters, but their associated GPs will receive a digital nudge letter. The letter will inform the GPs of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter will also include the definition of CKD and a summary of the guidelines. |
| No patient letters + no GP letter | No intervention | –Neither patients with CKD nor their associated GPs will receive digital nudge letters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age +18 years
- Diagnosis of CKD defined as at least one hospital encounter with the following ICD-10 codes in the primary diagnostic positions within ≤ 5 years: N18- N19, I12, E102, E112, E132, E142.
Key exclusion criteria (5 listed)
- 1) Exemption from the official, mandatory Danish electronic mailbox system.
- Individuals on a patient list of general practice clinics run by Danish administrative Regions.
- Individuals not on a patient list of a general practice.
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 |
|---|---|---|
| Electronically delivered nudging letters to patients with CKDAlso: Patient lettersPatients in the active arm will receive a digital nudge letter as part of the study. The nudge letter will be delivered at baseline. Letters will be delivered through the official, mandatory Danish electronic letter system. The control arm will consist of patients with CKD randomized to not receive digital nudge letters (usual care). | Behavioural | Patient letters + GP letter., Patient letters + no GP letter. |
| Electronically delivered nudging letter to associated GPs of patients with CKDAlso: GP letterThe associated GPs of the patients in the active arm will receive one digital nudge letter as part of the study. The nudge letter will be delivered at baseline. The letters will be delivered through the official, mandatory Danish electronic letter system. The control arm will consist of patients with CKD whose associated GP was randomized to not receive a digital nudge letter (usual care). | Behavioural | No patient letters + GP letter, Patient letters + GP letter. |
Primary outcome
Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
Time frame: within 6 months
8 secondary outcomes
Number of participants with any prescription of renin-angiotensin system inhibition
Time frame: within 6 months
Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors
Time frame: within 6 months
Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
Time frame: within 6 months
Number of participants with a new prescription of renin-angiotensin system inhibition
Time frame: within 6 months
Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors
Time frame: within 6 months
Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
Time frame: within 6 months
Time from intervention delivery to a new prescription of renin-angiotensin system inhibition
Time frame: within 6 months
Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors
Time frame: within 6 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 29 Sep 2025.
- Derived from this study: PubMed 40481660Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall HGC, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. A Nationwide Factorial Randomized Trial of Electronic Nudges to Patients With Chronic Kidney Disease and Their General Practices for Increasing Guideline-Directed Medical Therapy: The NUDGE-CKD Trial. Circulation. 2025 Aug 12;152(6):369-383. doi: 10.1161/CIRCULATIONAHA.125.075403. Epub 2025 Jun 7.
- Derived from this study: PubMed 40174694Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall H, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. Rationale and design of NUDGE-CKD: A nationwide randomized factorial trial of electronic nudges for increasing guideline-directed medical therapy in chronic kidney disease. Am Heart J. 2025 Sep;287:61-78. doi: 10.1016/j.ahj.2025.03.015. Epub 2025 Mar 31.
- Individual participant dataSharing planned: Yes. Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Tor Biering-Sørensen, MD, MSc, MPH, PhD principal investigator
Study Principal Investigator Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronically delivered nudging letters to patients with CKD and Electronically delivered nudging letter to associated GPs of patients with CKD in people with Chronic Kidney Diseases and Behavior and Behavior Mechanisms, run by Tor Biering-Sørensen at 1 site in Denmark.
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 5 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 29 Sep 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 Denmark. 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?
Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors (time frame: within 6 months). 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 NCT06300086, which also lists 2 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 29 Sep 2025.