Chronic Kidney DiseaseGUARDD-USNCT04191824

Genetic Testing to Understand and Address Renal Disease Disparities Across the United States

A study testing Timing of return of results in people with Chronic Kidney Disease and Hypertension, run by Duke University at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Kidney Disease, Hypertension
What is being tested?: Timing of return of results
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6,789 participants
Where: 14 sitesUnited States
Study dates: 10 Jul 2020to 17 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Self reported African ancestry
English Speaking
Age 18-70 years
Have diagnosis of hypertension: Diagnosis of hypertension is defined by either:
ICD10 diagnosis codes (i.e., I10; I11.x; I12.x; I13.x; I16.x) OR
On active antihypertensive therapy for indication of hypertension OR

Show all 12Show fewer

Having systolic blood pressure of 140 mm Hg or greater in at least 2 of the last 3 consecutive recorded values in the EHR OR
Having hypertension in the patient's medical record problem list
Have been seen at ≥1 time in past year at a participating primary care site
Either: 1) do not have diabetes and do not have CKD, or 2) have CKD; Participants with diabetes may be included as long as they also have CKD.
CKD is defined by either: A) ICD10 codes (i.e., N18.x; E08.22; E09.22; E10.22; E11.22;E13.22 (exclude Z94.0; N18.6; Z99.2)) OR B) Microalbumin/proteinuria level >30 mg/g for 2 time periods ≥ 3 months. Values taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months of enrollment. OR C) 15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months. GFRs are taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months.
Diabetes is defined by: HbA1c ≥ 6.5 at least one time in the last year OR ICD10 diagnosis codes OR Having diabetes in the patient's medical record problem list.

Who cannot join

Have diabetes, but no CKD.
Are currently on dialysis (ICD 10 codes N18.6, Z99.2 and Z94.0)
Have ESRD (eGFR<15 ml/min)
Have a left ventricular assist device (LVAD)
Have a terminal illness
Have patient-reported known pregnancy at time of enrollment

Show all 12Show fewer

Have had a liver, kidney, or allogeneic bone marrow transplant
Too cognitively impaired to provide informed consent and/or complete the study protocol
Institutionalized or too ill to participate (i.e. incarcerated, psychiatric or nursing home facility)
Plan to move out of the area within 6 months of enrollment
Not a current patient seeing a provider who cares for their hypertension (i.e., family medicine, internal medicine, nephrology, HIV provider, cardiology, hypertension specialists) at a participating site
Previously participated in the GUARDD pilot study OR have previously undergone APOL1 testing

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Baylor Research Institute
Dallas, Texas, 75210
University of Florida - Gainesville
Gainesville, Florida, 32610
Eskenazi Health
Indianapolis, Indiana, 46202
Indiana University
Indianapolis, Indiana, 46202
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Southeastern Healthcare
Lumberton, North Carolina, 28358
Meharry Medical College
Nashville, Tennessee, 37208
Nashville General Hospital
Nashville, Tennessee, 37208
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Institute for Family Health
New York, New York, 10035
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

GUARDD-US is a prospective, multicenter, unblinded, two arm randomized pragmatic clinical trial. Participants will be randomized in a 1:1 ratio to immediate APOL1 gene testing and return of results (ROR) to participant and provider (Intervention arm) versus delayed APOL1 gene testing and ROR to participant and provider (Control arm). The main study will compare outcomes between APOL1 positive participants in the Intervention arm (i.e., early knowledge of APOL1 status) to APOL1 positive participants in the Control arm (i.e., delayed knowledge of APOL1 status). Participants that are APOL1 negative in the Intervention and Control groups will not be included in the main study analyses.

GUARDD-US also includes a substudy to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP from baseline to 3 months in APOL1 negative individuals at participating sites.

This substudy is listed separately on clinicaltrials.gov as NCT06748040 and Unique Protocol ID - PRO00102997_A

Read the detailed description

High-risk variants in the APOL1 gene explain approximately 70% of the excess prevalence of CKD in African Americans (AAs), conferring a 5 times higher risk for hypertensive CKD and a 10 times higher risk for ESRD. A pilot study (GUARDD), showed that returning APOL1 gene test results had a statistically significant improvement in SBP at 3 months when comparing APOL1 positives to APOL1 negatives who received their genetic testing results and when comparing APOL1 positives that received their results early to overall controls who did not receive their results until after the 3 month visit. GUARDD was not however powered to evaluate the effects of having and knowing a positive APOL1 status on outcomes for those with high risk of developing CKD (i.e., comparing outcomes for APOL1 positive patients who know their genetic risk to APOL1 positive patients who do not know their genetic risk). A broader trial is needed to better determine the importance of APOL1 gene testing for improving the testing, diagnosis, and treatment of individuals at risk of CKD.

The primary aim is to determine the effect of participant and provider knowledge of a positive APOL1 status and accompanying guideline based clinical decision support (CDS) on blood pressure management on change in systolic blood pressure (SBP) from baseline to 3 months after randomization among the APOL1 positive participants. Secondary aims are to:

Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of documented CKD diagnosis.
Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of receiving a urine microalbumin/creatinine testing and ACE-I/ARB prescription based on results of the urine microalbumin level.
Explore cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of participant and provider knowledge of APOL1 status on provider treatment recommendations.

Approximately 6,750 participants of African ancestry age 18-70 with hypertension that either: 1) do not have diabetes and do not have CKD, or 2) have CKD. Participants with diabetes may be included as long as they also have CKD.

Population for Main Study:

Participants from Randomized Population (above) who test positive for APOL1

Main Study Analyses:

To determine the effect of participant and provider knowledge of a positive APOL1 status on SBP, we will compare the change in SBP from baseline to 3 months of the Intervention - APOL1 positive group to the change in SBP from baseline to 3 months of the Control - APOL1 positive group using a two sided t-test, as appropriate, with an overall two-sided type I error of 0.05.
The effect of knowledge of a positive APOL1 status on all secondary endpoints will be compared between Intervention - APOL1 positives to Control - APOL1 positives with the proportion difference test.
Additional analyses will include analysis of time trends in SBP, subset analyses, and exploratory analyses of cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of knowledge of APOL1 status on provider treatment recommendations.

Conditions: Chronic Kidney Disease, Hypertension
Being tested: Timing of return of results
Keywords: Kidney Disease, Genetic testing, APOL1, Genomics, Renal Disease
Medical subject headings: Renal Insufficiency, Chronic, Hypertension, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timing of return of resultsOther
Participants will be randomized to immediate versus delayed APOL1 return of results

Study groups in NCT04191824
Study group	Role	What they receive
Immediate Return of Results	Active comparator	Immediate return of results to inform participant of APOL1 status (either positive or negative). Receives: Other: Timing of return of results
Delayed Return of Results	Active comparator	Delayed return of results of APOL1 status (either positive or negative) after the completion of the 6 month final study visit. Receives: Other: Timing of return of results

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Positive Participants.
Measured: Baseline to 3 month study visit

Secondary outcomes (6)

Change in Number of Participants With Urine Microalbuminuria/Proteinuria Orders
Measured: Baseline to 6 month study visit
Number of Participants With Documented Order of Microalbuminuria/Proteinuria Tests
Measured: From baseline to 6 month study visit
Number of Participants With a Change in Documented Diagnosis for Stage 3 CKD and Above
Measured: From baseline to 6 month study visit
Number of Participants With Documented Diagnosis of CKD Stage 3 and Above
Measured: From baseline to 6 month study visit
Number of Participants With a Change in Documented Diagnosis for Any Stage CKD
Measured: From baseline to 6 month study visit
Number of Participants With Documented Diagnosis of All Stages of CKD
Measured: From baseline to 6 month study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202017 May 2024

First posted10 Dec 2019
Study start10 Jul 2020
Primary completion9 Apr 2024
Study completion17 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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: Parallel groups
Model description: Immediate versus delayed return of Apolipoprotein L1 (APOL1) genetic testing results to provider and participant.
Masking: None (open label)
Enrolment: 6,789 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04191824
Sponsor's protocol ID: PRO00102997
Other IDs: U01HG010225, U01HG007269, U01HG010232, U01HG010248, U01HG010231, U01HG010245
Acronym: GUARDD-US
Status last verified: Mar 2026
First submitted: 5 Dec 2019
Last updated: 25 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The Data Coordinating Center (DCC) will submit de-identified participant level datasets and associated documentation to the NHGRI's data repository - Genomic Analysis, Visualization and Informatics Lab-space (AnVIL), for use by other investigators. The datasets and associated documentation will be available after publication of the primary results manuscript. Documentation will include annotated case report forms, list of derived variables along with descriptions, and a description of the data model and de-identification process.

Publications

Eadon MT, Cavanaugh KL, Orlando LA, Christian D, Chakraborty H, Steen-Burrell KA, Merrill P, Seo J, Hauser D, Singh R, Beasley CM, Fuloria J, Kitzman H, Parker AS, Ramos M, Ong HH, Elwood EN, Lynch SE, Clermont S, Cicali EJ, Starostik P, Pratt VM, Nguyen KA, Rosenman MB, Calman NS, Robinson M, Nadkarni GN, Madden EB, Kucher N, Volpi S, Dexter PR, Skaar TC, Johnson JA, Cooper-DeHoff RM, Horowitz CR; GUARDD-US Investigators. Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension. Contemp Clin Trials. 2022 Aug;119:106813. doi: 10.1016/j.cct.2022.106813. Epub 2022 Jun 1.
PubMed 35660539
Eadon MT, Cavanaugh KL, She L, Steen-Burrell KA, Mohottige D, Nadkarni GN, Kitzman H, Chakraborty H, Empey PE, Limdi NA, Singh R, Beasley CM, Parker AS, Cicali EJ, Ramos MA, Clermont S, Dodgen L, Elwood EN, Robinson M, Umeukeje EM, Garcia Ortega A, Shroff N, Rosenman MB, Nguyen KA, Volpi S, Rider R, Dexter PR, Skaar TC, Peterson JF, Cavallari LH, Johnson JA, Wyatt CM, Orlando LA, Cooper-DeHoff RM, Horowitz CR; Implementing Genomics in Practice (IGNITE) Pragmatic Trials Network. Genetic Testing for APOL1 in Adults With Hypertension: The GUARDD-US Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260528. doi: 10.1001/jamanetworkopen.2026.0528.
PubMed 41784962

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
ClinicalTrials.gov ID: NCT04191824
Acronym / sponsor ID: GUARDD-US / PRO00102997
Conditions: Chronic Kidney Disease, Hypertension
Keywords: Kidney Disease, Genetic testing, APOL1, Genomics, Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 6,789 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Human Genome Research Institute (NHGRI), Icahn School of Medicine at Mount Sinai, University of Florida, Indiana University, Vanderbilt University Medical Center
Study start: 10 Jul 2020 (actual)
Primary completion: 9 Apr 2024 (actual)
Study completion: 17 May 2024 (actual)
First posted: 10 Dec 2019 (actual)
Results: Posted 30 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This substudy is listed separately on clinicaltrials.gov as NCT06748040 and Unique Protocol ID - PRO00102997_A

Detailed description

Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of documented CKD diagnosis.
Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of receiving a urine microalbumin/creatinine testing and ACE-I/ARB prescription based on results of the urine microalbumin level.
Explore cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of participant and provider knowledge of APOL1 status on provider treatment recommendations.

Population for Main Study:

Participants from Randomized Population (above) who test positive for APOL1

Main Study Analyses:

To determine the effect of participant and provider knowledge of a positive APOL1 status on SBP, we will compare the change in SBP from baseline to 3 months of the Intervention - APOL1 positive group to the change in SBP from baseline to 3 months of the Control - APOL1 positive group using a two sided t-test, as appropriate, with an overall two-sided type I error of 0.05.
The effect of knowledge of a positive APOL1 status on all secondary endpoints will be compared between Intervention - APOL1 positives to Control - APOL1 positives with the proportion difference test.
Additional analyses will include analysis of time trends in SBP, subset analyses, and exploratory analyses of cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of knowledge of APOL1 status on provider treatment recommendations.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Immediate versus delayed return of Apolipoprotein L1 (APOL1) genetic testing results to provider and participant.

Arm	Type	Receives
Immediate Return of Results	Active comparator	Other: Timing of return of resultsImmediate return of results to inform participant of APOL1 status (either positive or negative).
Delayed Return of Results	Active comparator	Other: Timing of return of resultsDelayed return of results of APOL1 status (either positive or negative) after the completion of the 6 month final study visit.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Self reported African ancestry
English Speaking
Age 18-70 years
Have diagnosis of hypertension: Diagnosis of hypertension is defined by either:
Have been seen at ≥1 time in past year at a participating primary care site

Key exclusion criteria (12 listed)

Have diabetes, but no CKD.
Are currently on dialysis (ICD 10 codes N18.6, Z99.2 and Z94.0)
Have ESRD (eGFR<15 ml/min)
Have a left ventricular assist device (LVAD)
Have a terminal illness

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
Timing of return of resultsParticipants will be randomized to immediate versus delayed APOL1 return of results	Other	Delayed Return of Results, Immediate Return of Results

Primary outcome

Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Positive Participants.
Time frame: Baseline to 3 month study visit

6 secondary outcomes

Change in Number of Participants With Urine Microalbuminuria/Proteinuria Orders
Time frame: Baseline to 6 month study visit
Number of Participants With Documented Order of Microalbuminuria/Proteinuria Tests
Time frame: From baseline to 6 month study visit
Number of Participants With a Change in Documented Diagnosis for Stage 3 CKD and Above
Time frame: From baseline to 6 month study visit
Number of Participants With Documented Diagnosis of CKD Stage 3 and Above
Time frame: From baseline to 6 month study visit
Number of Participants With a Change in Documented Diagnosis for Any Stage CKD
Time frame: From baseline to 6 month study visit
Number of Participants With Documented Diagnosis of All Stages of CKD
Time frame: From baseline to 6 month study visit

Results and safety

Results posted to the registry on 30 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Return of Results	3,380	2,869
Delayed Return of Results	3,374	2,884

Primary outcome: Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Positive Participants.

Time frame: Baseline to 3 month study visit. Mean (Standard Deviation). Unit: mmHg

Measure	Immediate Return of Results (Modified Intent to Treat, mITT) n = 446	Delayed Return of Results (Modified Intent to Treat, mITT) n = 428
Value	-1.8 (18.8)	-1.5 (17.3)

Immediate Return of Results (Modified Intent to Treat, mITT) vs Delayed Return of Results (Modified Intent to Treat, mITT): Mean Difference (Final Values): -0.3 (95% CI -2.7 to 2.1), p = 0.7769, t-test, 2 sided

Population analysed: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Return of Results (Intent to Treat, ITT)	0 of 0	0 of 0	13 of 3,380
Delayed Return of Results (Intent to Treat, ITT)	0 of 0	0 of 0	12 of 3,374

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35660539Eadon MT, Cavanaugh KL, Orlando LA, Christian D, Chakraborty H, Steen-Burrell KA, Merrill P, Seo J, Hauser D, Singh R, Beasley CM, Fuloria J, Kitzman H, Parker AS, Ramos M, Ong HH, Elwood EN, Lynch SE, Clermont S, Cicali EJ, Starostik P, Pratt VM, Nguyen KA, Rosenman MB, Calman NS, Robinson M, Nadkarni GN, Madden EB, Kucher N, Volpi S, Dexter PR, Skaar TC, Johnson JA, Cooper-DeHoff RM, Horowitz CR; GUARDD-US Investigators. Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension. Contemp Clin Trials. 2022 Aug;119:106813. doi: 10.1016/j.cct.2022.106813. Epub 2022 Jun 1.
Results publication: PubMed 41784962Eadon MT, Cavanaugh KL, She L, Steen-Burrell KA, Mohottige D, Nadkarni GN, Kitzman H, Chakraborty H, Empey PE, Limdi NA, Singh R, Beasley CM, Parker AS, Cicali EJ, Ramos MA, Clermont S, Dodgen L, Elwood EN, Robinson M, Umeukeje EM, Garcia Ortega A, Shroff N, Rosenman MB, Nguyen KA, Volpi S, Rider R, Dexter PR, Skaar TC, Peterson JF, Cavallari LH, Johnson JA, Wyatt CM, Orlando LA, Cooper-DeHoff RM, Horowitz CR; Implementing Genomics in Practice (IGNITE) Pragmatic Trials Network. Genetic Testing for APOL1 in Adults With Hypertension: The GUARDD-US Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260528. doi: 10.1001/jamanetworkopen.2026.0528.
Genetic Testing for APOL1 in Adults With Hypertension: The GUARDD-US Randomized Clinical TrialLink provided by the sponsor.
Individual participant dataSharing planned: Yes. The Data Coordinating Center (DCC) will submit de-identified participant level datasets and associated documentation to the NHGRI's data repository - Genomic Analysis, Visualization and Informatics Lab-space (AnVIL), for use by other investigators. The datasets and associated documentation will be available after publication of the primary results manuscript. Documentation will include annotated case report forms, list of derived variables along with descriptions, and a description of the data model and de-identification process.

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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.

Hrishikesh Chakraborty, DrPH study director

Duke University

Carol Horowitz, MD principal investigator

Icahn School of Medicine at Mount Sinai

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Timing of return of results in people with Chronic Kidney Disease and Hypertension, run by Duke University at 14 sites in United States.

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 12 inclusion and 12 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Systolic Blood Pressure From Baseline to 3 Months for APOL1 Positive Participants. (time frame: Baseline to 3 month study visit). 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 NCT04191824, 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 25 Mar 2026.