Heart Failure With Reduced Ejection Fraction (HFrEF)Phase 1Re-PERFUSENCT06611423
AZD3427 Effects on Renal Perfusion in Heart Failure Patients With Reduced Ejection Fraction and Renal Impairment
A Phase 1 study testing AZD3427, Dopamine and Radiolabelled ligand in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and Renal Impairment, run by AstraZeneca at 1 site in Sweden.
Trial summary
The present study is designed to test the effect of AZD3427 on renal perfusion in participants with heart failure and reduced eGFR (30 to 90 mL/min/1.73m2). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF), Renal Impairment
- What is being tested?
- AZD3427, Dopamine and Radiolabelled ligand
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 15 Oct 2024to 21 Aug 2025
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AGE:
- Participant must be > 20 years-old at the time of signing the informed consent.
- DISEASE CHARACTERISTICS:
- Participant must have suitable veins for cannulation.
- Participants must have a known clinical diagnosis of HF NYHA I to III for at least 12 months.
- Participants must be on stable HF standard of care medication for at least 4 weeks prior to screening, with no significant dose change or new medications added during that period. If the participant is currently taking diuretics, then diuretics must also be stable for at least 4 weeks prior to screening. It is also expected that there will be no change in treatment between screening (Visit 1) and Visit 3 in terms of drugs known to affect renal haemodynamics, including but not limited to: ACE-Is, angiotensin II receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, cyclooxygenase inhibitors, endothelin receptors antagonists, phosphodiesterase inhibitors, SGLT2is, and diuretics.
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- Participants must have a left ventricular ejection fraction of ≤ 40% based on echocardiography conducted within the last 6 months.
- Participants must have an eGFR of 30 to 90 mL/min/1.73 m2 (inclusive) assessed by the CKD-EPI, 2021 (creatinine only) equation without including race (Inker et al 2021) at screening.
- BMI AND WEIGHT:
- Participants must have a minimum BMI of 18.0 kg/m2 and a minimum body weight of 50 kg at screening.
- SEX AND CONTRACEPTIVE REQUIREMENTS:
- For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening by one of the following:
- Postmenopausal, defined as amenorrhoea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with FSH levels in the postmenopausal range.
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilisation.
- All male participants should refrain from fathering a child or donating sperm until 3 months after dosing. The female partner has to be either of non-childbearing potential or has to use a highly effective contraception form of birth control until 3 months after dosing. The female partner should be stable on their chosen method of birth control for at least 3 months prior to dosing.
- Male participants who have been sterilised are required to use one barrier method of contraception (condom) from the time of study intervention administration until 3 months after the dosing. The participant must have received medical assessment of the surgical success.
- INFORMED CONSENT:
- Capable of and willing to give signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- MEDICAL CONDITIONS:
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of screening or planned surgical or other procedure before study completion.
- Clinically significant, as judged by the investigator, ventricular arrhythmias requiring pharmacological treatment.
- Historical or current evidence of a clinically significant disease or disorder including, but not limited to:
- Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, percutaneous coronary intervention, implantable cardioverter defibrillator implantation, within 12 weeks prior to screening.
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- Primary cardiomyopathy other than dilated, including but not limited to sarcoidosis, amyloidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, complex congenital heart disease.
- Decompensated HF or hospitalisation due to any cause < 4 weeks prior to screening.
- Severe heart valve disease.
- Diagnosis of polycystic kidney disease or anatomical causes of chronic kidney disease.
- One kidney, renal artery stenosis, or glomerulonephritis.
- Anticipated dialysis or renal transplantation within 1 year.
- Condition where vasodilatory therapy maybe contraindicated for example but not limited to severe aortic stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy.
- History of active malignancy within 2 years, with the exception of fully excised or treated basal cell carcinoma or ≤ 2 squamous cell carcinomas of the skin.
- Participants who are under investigation for breast or cervical cancer, including participants with a pap smear of ≥ 3. All investigations must be resolved as negative for breast and cervical cancer at least 12 weeks before screening.
- Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator.
- Known or suspected history of drug abuse as judged by the Investigator.
- History of alcohol abuse or excessive intake of alcohol as judged by the Investigator, within the 6 months prior to screening.
- History of hypersensitivity to injection devices or to drugs with a similar chemical structure or class to AZD3427 or any component of the AZD3427 preparation, or to dopamine or any component of the dopamine preparation, or ongoing clinically important allergy/hypersensitivity.
- Participants who cannot communicate reliably with the Investigator.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Known history of ADAs to relaxin or relaxin analogues.
- Active infections that significantly affect the patient's health status or in the opinion of the Investigator, may put the participant at risk (eg, HIV, Hepatitis, tuberculosis, etc.).
- Plasma donation within 1 month prior to screening or any blood donation/blood loss > 500 mL during the 3 months prior to screening.
- PRIOR/CONCOMITANT THERAPY:
- If on treatment with other drugs with potential to significantly influence on eGFR (eg, SGLT2i, ACE-I), the participant must have been on a stable dose for at least 4 weeks prior to screening.
- PDE-5 inhibitors such as sildenafil (eg, taken for erectile dysfunction or other as-needed reasons) and NSAIDs such as diclofenac and ibuprofen should not be taken for 2 days before the PET Sessions 2 and 3 (Visit 2 and Visit 3); paracetamol is allowed.
- PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE:
- Currently participating in or previous participation in another clinical study within 30 days prior to the Screening Visit or previous participation in another PET imaging trial within the last 12 months, or planned participation in such study prior to end of the Follow-up period.
- Note: Participants consented and screened, but not entered in this study or a previous study, are not excluded.
- DIAGNOSTIC ASSESSMENTS:
- Haemoglobin < 100 g/L at Screening.
- Abnormal vital signs defined as any of the following at screening:
- Sitting SBP > 160 mmHg or sitting DBP > 110 mmHg after a period of at least 5 minutes of rest;
- Sitting SBP < 100 mmHg or sitting DBP < 50 mmHg;
- Resting pulse rate of < 50 bpm or > 115 bpm.
- OTHER EXCLUSIONS:
- Involvement of any AstraZeneca, CRO, or study centre employee or their close relatives, including any involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgement by the Investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrolment or randomisation in the present study.
- For females only: currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib, Double-blind, Placebo-controlled, Randomised Trial Investigating the Effect of AZD3427 on Renal Perfusion in HFrEF Patients With Renal Impairment Using Positron Emission Tomography (PET)
The present study is designed to test the effect of AZD3427 on renal perfusion in participants with heart failure and reduced eGFR (30 to 90 mL/min/1.73m2).
Read the detailed description
This is a Phase Ib randomised, double-blind, placebo-controlled, single-dose, single-centre study to evaluate the renal haemodynamic effects of AZD3427 in participants with heart failure and reduced eGFR. This study will evaluate changes in the volumetric fraction of perfused renal cortex after a single dose of AZD3427 or AZD3427 placebo. These changes will be assessed using [15O]H2O PET imaging of the kidneys. Additional endpoints include changes in total renal perfusion, plasma/serum biomarkers of renal function, and safety and tolerability. Infusion with 2 to 4 µg/kg/min dopamine/saline placebo will be used as a positive control.
Study details include:
- The study duration will be up to 83 days.
- The treatment duration will be 1 day.
- The visit frequency will be on Day 1, Day 8 (± 3 days), and Day 56 (± 3 days).
- Being tested
- AZD3427, AZD3427 Placebo, Dopamine, Radiolabelled ligand, Saline
- Keywords
- Heart failure with reduced ejection fraction, HFrEF, Renal impairment, Reduced eGFR, AZD3427, PET
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3427Biological
AZD3427 SC injection to be prepared using AZD3427 diluent
AZD3427 PlaceboOther
AZD3427 Placebo
DopamineDrug
Dopamine Hydrochloride 50mg/5mL
Radiolabelled ligandOther
Injection of radioligand for PET examinations
SalineOther
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| IV Saline placebo followed by SC AZD3427 | Experimental | Participants will receive IV administration of saline only placebo prior to a PET examination. This is followed by a single SC dose of AZD3427 on Day 1 (V2). Receives: Biological: AZD3427; Other: Radiolabelled ligand; Other: Saline |
| IV Saline placebo followed by SC AZD3427 placebo | Placebo comparator | Participants will receive IV administration of saline only placebo prior to a PET examination. This is followed by a single SC dose of AZD3427 Placebo on Day 1 (V2). Receives: Other: AZD3427 Placebo; Other: Radiolabelled ligand; Other: Saline |
| IV Dopamine diluted in saline followed by SC AZD3427 | Experimental | Participants will receive IV administration of dopamine diluted in saline prior to a PET examination. This is followed by a single SC dose of AZD3427 on Day 1 (V2) Receives: Biological: AZD3427; Drug: Dopamine; Other: Radiolabelled ligand |
| IV Dopamine diluted in saline followed by SC AZD3427 placebo | Placebo comparator | Participants will receive IV administration of dopamine diluted in saline prior to a PET examination. This is followed by a single SC dose of AZD3427 Placebo on Day 1 (V2). Receives: Other: AZD3427 Placebo; Drug: Dopamine; Other: Radiolabelled ligand |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volumetric fraction (%) of the renal cortex with increased perfusion from baseline to Day 8, compared to placebo.
A PET image analysis of renal cortex measures the perfusion in approximately 8000 voxels. The volumetric fraction (%) is the fraction of voxels (%) with a positive change, i.e. increased perfusion.
Measured: Baseline to Day 8
Secondary outcomes (3)
Number of participants with adverse events (AEs)
Number of participants with adverse events with onset after dose.
Measured: Baseline to Day 56
Number of participants with abnormal vital signs
Predefined criteria for treatment-emergent changes in vital sign parameters will be used.
Measured: Baseline to Day 56
Number of participants with abnormal laboratory tests results
Predefined criteria for treatment-emergent changes in laboratory parameters will be used.
Measured: Baseline to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start15 Oct 2024
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Why it stopped: The Sponsor encountered difficulties in recruiting patients for clinical trial D8330C00004 and decided to end the study earlier for business reasons not affecting the benefit-risk balance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Kaveh Azizi, MD, Principal investigator, Clinical Trial Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611423
- Sponsor's protocol ID
- D8330C00004
- Acronym
- Re-PERFUSE
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Double-blind, Placebo-controlled, Randomised Trial Investigating the Effect of AZD3427 on Renal Perfusion in HFrEF Patients With Renal Impairment Using Positron Emission Tomography (PET)
- ClinicalTrials.gov ID
- NCT06611423
- Acronym / sponsor ID
- Re-PERFUSE / D8330C00004
- Keywords
- Heart failure with reduced ejection fraction, HFrEF, Renal impairment, Reduced eGFR, AZD3427, PET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor encountered difficulties in recruiting patients for clinical trial D8330C00004 and decided to end the study earlier for business reasons not affecting the benefit-risk balance.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Karolinska Institutet
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 25 Sep 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.
The present study is designed to test the effect of AZD3427 on renal perfusion in participants with heart failure and reduced eGFR (30 to 90 mL/min/1.73m2).
Detailed description
This is a Phase Ib randomised, double-blind, placebo-controlled, single-dose, single-centre study to evaluate the renal haemodynamic effects of AZD3427 in participants with heart failure and reduced eGFR. This study will evaluate changes in the volumetric fraction of perfused renal cortex after a single dose of AZD3427 or AZD3427 placebo. These changes will be assessed using [15O]H2O PET imaging of the kidneys. Additional endpoints include changes in total renal perfusion, plasma/serum biomarkers of renal function, and safety and tolerability. Infusion with 2 to 4 µg/kg/min dopamine/saline placebo will be used as a positive control.
Study details include:
- The study duration will be up to 83 days.
- The treatment duration will be 1 day.
- The visit frequency will be on Day 1, Day 8 (± 3 days), and Day 56 (± 3 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IV Saline placebo followed by SC AZD3427 | Experimental | Biological: AZD3427, Other: Radiolabelled ligand, Other: SalineParticipants will receive IV administration of saline only placebo prior to a PET examination. This is followed by a single SC dose of AZD3427 on Day 1 (V2). |
| IV Saline placebo followed by SC AZD3427 placebo | Placebo comparator | Other: AZD3427 Placebo, Other: Radiolabelled ligand, Other: SalineParticipants will receive IV administration of saline only placebo prior to a PET examination. This is followed by a single SC dose of AZD3427 Placebo on Day 1 (V2). |
| IV Dopamine diluted in saline followed by SC AZD3427 | Experimental | Biological: AZD3427, Drug: Dopamine, Other: Radiolabelled ligandParticipants will receive IV administration of dopamine diluted in saline prior to a PET examination. This is followed by a single SC dose of AZD3427 on Day 1 (V2) |
| IV Dopamine diluted in saline followed by SC AZD3427 placebo | Placebo comparator | Other: AZD3427 Placebo, Drug: Dopamine, Other: Radiolabelled ligandParticipants will receive IV administration of dopamine diluted in saline prior to a PET examination. This is followed by a single SC dose of AZD3427 Placebo on Day 1 (V2). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participant must be > 20 years-old at the time of signing the informed consent.
- Participant must have suitable veins for cannulation.
- Participants must have a known clinical diagnosis of HF NYHA I to III for at least 12 months.
- Participants must be on stable HF standard of care medication for at least 4 weeks prior to screening, with no significant dose change or new medications added during that period. If the participant is currently taking diuretics, then diuretics must also be stable for at least 4 weeks prior to screening. It is also expected that there will be no change in treatment between screening (Visit 1) and Visit 3 in terms of drugs known to affect renal haemodynamics, including but not limited to: ACE-Is, angiotensin II receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, cyclooxygenase inhibitors, endothelin receptors antagonists, phosphodiesterase inhibitors, SGLT2is, and diuretics.
- Participants must have a left ventricular ejection fraction of ≤ 40% based on echocardiography conducted within the last 6 months.
Key exclusion criteria (41 listed)
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of screening or planned surgical or other procedure before study completion.
- Clinically significant, as judged by the investigator, ventricular arrhythmias requiring pharmacological treatment.
- Historical or current evidence of a clinically significant disease or disorder including, but not limited to:
- Decompensated HF or hospitalisation due to any cause < 4 weeks prior to screening.
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 |
|---|---|---|
| AZD3427AZD3427 SC injection to be prepared using AZD3427 diluent | Biological | IV Dopamine diluted in saline followed by SC AZD3427, IV Saline placebo followed by SC AZD3427 |
| AZD3427 PlaceboAZD3427 Placebo | Other | IV Dopamine diluted in saline followed by SC AZD3427 placebo, IV Saline placebo followed by SC AZD3427 placebo |
| DopamineDopamine Hydrochloride 50mg/5mL | Drug | IV Dopamine diluted in saline followed by SC AZD3427, IV Dopamine diluted in saline followed by SC AZD3427 placebo |
| Radiolabelled ligandInjection of radioligand for PET examinations | Other | IV Dopamine diluted in saline followed by SC AZD3427, IV Dopamine diluted in saline followed by SC AZD3427 placebo, IV Saline placebo followed by SC AZD3427, IV Saline placebo followed by SC AZD3427 placebo |
| SalineSaline solution | Other | IV Saline placebo followed by SC AZD3427, IV Saline placebo followed by SC AZD3427 placebo |
Primary outcome
The volumetric fraction (%) of the renal cortex with increased perfusion from baseline to Day 8, compared to placebo.
Time frame: Baseline to Day 8
A PET image analysis of renal cortex measures the perfusion in approximately 8000 voxels. The volumetric fraction (%) is the fraction of voxels (%) with a positive change, i.e. increased perfusion.
3 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Baseline to Day 56
Number of participants with abnormal vital signs
Time frame: Baseline to Day 56
Number of participants with abnormal laboratory tests results
Time frame: Baseline to Day 56
Results and safety
The study was stopped early (reason given: The Sponsor encountered difficulties in recruiting patients for clinical trial D8330C00004 and decided to end the study earlier for business reasons not affecting the benefit-risk balance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Kaveh Azizi, MD principal investigator
Clinical Trial Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3427, Dopamine and Radiolabelled ligand in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and Renal Impairment, run by AstraZeneca at 1 site in Sweden.
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 18 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 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 Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The Sponsor encountered difficulties in recruiting patients for clinical trial D8330C00004 and decided to end the study earlier for business reasons not affecting the benefit-risk balance.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volumetric fraction (%) of the renal cortex with increased perfusion from baseline to Day 8, compared to placebo. (time frame: Baseline to Day 8). 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 24 Sep 2025.