Autosomal Dominant Polycystic KidneyPhase 2NCT03203642

Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD

A Phase 2 study testing Tesevatinib in people with Autosomal Dominant Polycystic Kidney and ADPKD, run by Kadmon, a Sanofi Company at 19 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

The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD). Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Autosomal Dominant Polycystic Kidney, ADPKD
What is being tested?: Tesevatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 19 sitesUnited States
Study dates: 12 Oct 2017to 25 Jan 2022
Phase: Phase 2
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

ADPKD diagnosis based on Ravine's criteria.
Cysts of at least 1 centimeter.
Estimated glomerular filtration rate greater than or equal to (>=) 25 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) and less than or equal to (<=) 90 mL/min/1.73 m^2, using the Modification of Diet in Renal Disease-4 variable formula.
htTKV must meet the following requirements: >= 500 milliliters (mL) for participants 18-35 years of age; >= 750 mL for participants 36-49 years of age; >= 900 mL for participants 50-60 years of age.
The participant had the following laboratory values:
Platelets greater than (>) lower limit of normal (LLN); Hemoglobin > 9 grams per deciliter; Total bilirubin <= 1.5 milligrams per deciliter; Aspartate aminotransferase less than (<) 2.5upper limit of normal (ULN); Alanine aminotransferase < 2.5ULN; Prothrombin time/partial thromboplastin time <=1.5ULN; Serum potassium levels within normal limits; Serum magnesium levels within normal limits; Albumin >= LLN; Amylase <=1.5ULN; Lipase <=1.5ULN; Prothrombin time and partial thromboplastin time <=1.5ULN; International normalized ratio (INR) <=1.5, except those participants taking warfarin who must have INR <=3.
Female participants of childbearing potential with negative pregnancy test at screening.
If sexually active, the participant agreed to use 2 accepted methods of contraception during the course of the study and for 6 months after their last dose of study drug.

Who cannot join

Previous nephrectomy.
Kidney transplant.
Tuberous sclerosis.
Hippel-Lindau disease.
Acquired cystic disease.
Congenital absence of 1 kidney and/or need for dialysis or transplantation in the foreseeable future.

Show all 33Show fewer

Moderate hematuria.
Uncontrolled hypertension.
Presence of renal or hepatic calculi (stones) causing symptoms.
Received any investigational therapy within 30 days prior to initiation of therapy (Day 1 visit).
Received tolvaptan 30 days prior to initiation of therapy (Day 1 visit).
Received active treatment for urinary tract infection 4 weeks prior to initiation of therapy (Day 1 visit).
History of pancreatitis or known risk of pancreatitis.
The participant met any of the following cardiac criteria:
Mean QTc interval corrected for heart rate using Fridericia's formula (QTcF) of >450 milliseconds.
History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 50 beats per minute), heart block (excluding first-degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on electrocardiogram.
Participants with a history of atrial arrhythmias were discussed with the Medical Monitor.
Family history of congenital long QT syndrome or unexplained cardiac death.
Symptomatic heart failure (per New York Heart Association guidelines), unstable angina, myocardial infarction, or cerebrovascular accident within 6 months prior to study entry.
History of ventricular rhythm disturbances.
History of cardiac arrhythmias, stroke, or myocardial infarction.
Has a cardiac pacemaker.
History of pericardial effusion or presence of pericardial effusion on screening echocardiogram.
Taking any medication known to inhibit the cytochrome P450 (CYP)3A4 isozyme or any drugs that are CYP3A4 inducers, or any drugs associated with torsade de pointes or known to prolong the QTcF interval, including anti-arrhythmic medications within 2 weeks prior to screening.
Uncontrolled intercurrent illness that would limit compliance with study requirements.
Participant was pregnant, planed to become pregnant, or nursing.
Human immunodeficiency virus positive.
Hepatitis B or C positive.
Immunocompromised.
Documented renal vascular disease resulting in uncontrolled hypertension.
Previously received an epithelial growth factor receptor (EGFR).
Allergy or hypersensitivity to components of tesevatinib or placebo or their formulations.
Been aphakic due to previous cataract surgery or congenital abnormality.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22908
University of California San Diego
La Jolla, California, 92037
California Institute for Renal Research
La Mesa, California, 91942
University of California Los Angeles
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale Nephrology Clinical Research
New Haven, Connecticut, 06520
Rogosin Institute
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Coastal Nephrology Associates Research Center, LLC
Port Charlotte, Florida, 33952
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63110
Genesis Clinical Research
Tampa, Florida, 33614
Baylor Scott & White Research Institute
Temple, Texas, 10016

Other trials in United States

About this study

Official title: A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease

The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).

Read the detailed description

Safety and efficacy of 50 mg tesevatinib in comparison to placebo in participants with ADPKD was assessed.

The primary purpose of this study was focused on evaluating the change from Baseline in height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI) at Months 12, 18, and 24, and 30 days post-dose in participants with ADPKD treated with tesevatinib or placebo.

If eligible for the study participation, participants were randomly assigned to either investigational treatment group or placebo group. Treatment group received 50 mg tesevatinib once daily for 24 months and control group received the placebo once daily for 24 months.

Conditions: Autosomal Dominant Polycystic Kidney, ADPKD
Being tested: Tesevatinib, Placebo
Keywords: ADPKD, Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney, Tesevatinib, Polycystic Kidney Disease, PKD
Medical subject headings: Polycystic Kidney, Autosomal Dominant, Polycystic Kidney Diseases

What participants receive

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

TesevatinibDrug
Also called KD019
Pharmaceutical form: Tablet; Route of administration: orally
PlaceboDrug
Pharmaceutical form: Tablet (identical to tesevatinib); Route of administration: orally

Study groups in NCT03203642
Study group	Role	What they receive
Tesevatinib	Experimental	Participants received tesevatinib 50 mg tablet orally once daily (QD) for up to 25.3 months. Receives: Drug: Tesevatinib
Placebo	Placebo comparator	Participants received placebo matched to tesevatinib tablet orally QD for up to 25.3 months. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12
htTKV was calculated using total kidney volume (in milliliters) obtained from magnetic resonance imaging (MRI) divided by height (in meters). Least square (LS) mean and standard error (SE) were estimated by using analysis of covariance (ANCOVA) model. Change from Baseline in htTKV at Month 12 was reported in this outcome measure.
Measured: Baseline (Day 1), Month 12
Change From Baseline in Height Adjusted Total Kidney Volume at Month 18
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 18 was reported in this outcome measure.
Measured: Baseline (Day 1), Month 18
Change From Baseline in Height Adjusted Total Kidney Volume at Month 24
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 24 was reported in this outcome measure.
Measured: Baseline (Day 1), Month 24
Change From Baseline in Height Adjusted Total Kidney Volume at End of Study
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at end of study (i.e., up to 26 months) was reported in this outcome measure.
Measured: Baseline (Day 1), End of study (anytime up to 26 months)

Secondary outcomes (2)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until end of study.
Measured: From Baseline (Day 1) up to 30 days post last dose of study drug (i.e., up to 26 months)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 18, 24 and End of Study
eGFR is a test for renal function. eGFR was calculated by using the 4-variable modification of diet in renal disease (MDRD-4) formula reported as milliliters per minute per 1.73 square meter (mL/min/1.73 m^2). LS mean and SE were estimated using ANCOVA model.
Measured: Baseline (Day 1), Months 12, 18, 24 and at end of study (i.e., anytime up to 26 months)

Timeline

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

12 Oct 201725 Jan 2022

First posted29 Jun 2017
Study start12 Oct 2017
Primary completion25 Jan 2022
Study completion25 Jan 2022

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 (1)Papers the sponsor has linked to this study.
Other trials for Autosomal Dominant Polycystic KidneyStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03203642
Sponsor's protocol ID: ACT17675
Other IDs: KD019-211
Status last verified: Jan 2023
First submitted: 26 Jun 2017
Last updated: 6 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
PubMed 41385299

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?

See locations

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All Autosomal Dominant Polycystic Kidney trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease
ClinicalTrials.gov ID: NCT03203642
Acronym / sponsor ID: ACT17675
Conditions: Autosomal Dominant Polycystic Kidney, ADPKD
Keywords: ADPKD, Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney, Tesevatinib, Polycystic Kidney Disease, PKD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Kadmon, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 12 Oct 2017 (actual)
Primary completion: 25 Jan 2022 (actual)
Study completion: 25 Jan 2022 (actual)
First posted: 29 Jun 2017 (actual)
Results: Posted 6 Feb 2023

Clinical summary

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

The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).

Detailed description

Safety and efficacy of 50 mg tesevatinib in comparison to placebo in participants with ADPKD was assessed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tesevatinib	Experimental	Drug: TesevatinibParticipants received tesevatinib 50 mg tablet orally once daily (QD) for up to 25.3 months.
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo matched to tesevatinib tablet orally QD for up to 25.3 months.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

ADPKD diagnosis based on Ravine's criteria.
Cysts of at least 1 centimeter.
Estimated glomerular filtration rate greater than or equal to (>=) 25 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) and less than or equal to (<=) 90 mL/min/1.73 m^2, using the Modification of Diet in Renal Disease-4 variable formula.
htTKV must meet the following requirements: >= 500 milliliters (mL) for participants 18-35 years of age; >= 750 mL for participants 36-49 years of age; >= 900 mL for participants 50-60 years of age.
The participant had the following laboratory values:

Key exclusion criteria (33 listed)

Previous nephrectomy.
Kidney transplant.
Tuberous sclerosis.
Hippel-Lindau disease.
Acquired cystic disease.

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
TesevatinibAlso: KD019Pharmaceutical form: Tablet; Route of administration: orally	Drug	Tesevatinib
PlaceboPharmaceutical form: Tablet (identical to tesevatinib); Route of administration: orally	Drug	Placebo

Primary outcome

Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12
Time frame: Baseline (Day 1), Month 12
htTKV was calculated using total kidney volume (in milliliters) obtained from magnetic resonance imaging (MRI) divided by height (in meters). Least square (LS) mean and standard error (SE) were estimated by using analysis of covariance (ANCOVA) model. Change from Baseline in htTKV at Month 12 was reported in this outcome measure.
Change From Baseline in Height Adjusted Total Kidney Volume at Month 18
Time frame: Baseline (Day 1), Month 18
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 18 was reported in this outcome measure.
Change From Baseline in Height Adjusted Total Kidney Volume at Month 24
Time frame: Baseline (Day 1), Month 24
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 24 was reported in this outcome measure.
Change From Baseline in Height Adjusted Total Kidney Volume at End of Study
Time frame: Baseline (Day 1), End of study (anytime up to 26 months)
htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at end of study (i.e., up to 26 months) was reported in this outcome measure.

2 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline (Day 1) up to 30 days post last dose of study drug (i.e., up to 26 months)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 18, 24 and End of Study
Time frame: Baseline (Day 1), Months 12, 18, 24 and at end of study (i.e., anytime up to 26 months)

Results and safety

Results posted to the registry on 6 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tesevatinib	40	25
Placebo	40	29

Primary outcome: Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12

Time frame: Baseline (Day 1), Month 12. Least squares mean (Standard Error). Unit: milliliters per meter

Measure	Tesevatinib n = 31	Placebo n = 34
Value	0.0236 (0.0059)	0.0288 (0.0057)

Tesevatinib vs Placebo: LS mean difference: -0.0052 (95% CI -0.0217 to - 0.0112), p = 0.5265, ANCOVA

Population analysed: Analysis was performed on efficacy population which included all randomized participants who received at least 1 dose of study drug and completed at least 12 months of tesevatinib or placebo treatment and had a centrally read MRI at Baseline and after 12 months of treatment.

Primary outcome: Change From Baseline in Height Adjusted Total Kidney Volume at Month 18

Time frame: Baseline (Day 1), Month 18. Least squares mean (Standard Error). Unit: milliliters per meter

Measure	Tesevatinib n = 31	Placebo n = 34
Value	0.0383 (0.0081)	0.0425 (0.0075)

Tesevatinib vs Placebo: LS mean difference: -0.0042 (95% CI -0.0264 to - 0.0180), p = 0.7076, ANCOVA

Population analysed: Analysis was performed on efficacy population.

Primary outcome: Change From Baseline in Height Adjusted Total Kidney Volume at Month 24

Time frame: Baseline (Day 1), Month 24. Least squares mean (Standard Error). Unit: milliliters per meter

Measure	Tesevatinib n = 31	Placebo n = 34
Value	0.0485 (0.0103)	0.0607 (0.0095)

Tesevatinib vs Placebo: LS mean difference: -0.0122 (95% CI -0.0404 to - 0.0160), p = 0.3895, ANCOVA

Population analysed: Analysis was performed on efficacy population.

Primary outcome: Change From Baseline in Height Adjusted Total Kidney Volume at End of Study

Time frame: Baseline (Day 1), End of study (anytime up to 26 months). Least squares mean (Standard Error). Unit: milliliters per meter

Measure	Tesevatinib n = 31	Placebo n = 34
Value	0.0604 (0.0090)	0.0589 (0.0094)

Tesevatinib vs Placebo: LS mean difference: 0.0015 (95% CI -0.0248 to - 0.0278), p = 0.9093, ANCOVA

Population analysed: Analysis was performed on efficacy population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline (Day 1) up to 30 days post last dose of the study drug (i.e., up to 26 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tesevatinib	6 of 38 (15.8%)	37 of 38 (97.4%)	0 of 38
Placebo	2 of 40 (5%)	40 of 40 (100%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41385299Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tesevatinib in people with Autosomal Dominant Polycystic Kidney and ADPKD, run by Kadmon, a Sanofi Company at 19 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 8 inclusion and 33 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2023). 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 From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12 (time frame: Baseline (Day 1), Month 12). The study lists 4 primary outcomes in all. 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 NCT03203642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.