Renal ImpairmentPhase 1AURORANCT06639087
A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
A Phase 1 study testing AZD5462 and Dapagliflozin in people with Renal Impairment and Heart Failure, run by AstraZeneca at 1 site in Bulgaria.
Trial summary
A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Impairment, Heart Failure
- What is being tested?
- AZD5462 and Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteBulgaria
- Study dates
- 27 Sep 2024to 29 May 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a pre-existing diagnosis of heart failure (HF).
- Participants must have a left ventricular ejection fraction (LVEF) of ≤ 40% based on echocardiography taken within the last 9 months.
- Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) at Screening as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 (creatinine) equation.
- Participants must be on stable HF standard of care (SoC) medication for at least 4 weeks prior to Screening. If the participant is currently taking diuretics, then diuretics must also be stable for at least one week prior to Screening.
- Participants must be on stable Sodium-glucose co-transporter-2 inhibitors (SGLT2) inhibitor treatment for at least 12 weeks prior to Screening.
- Minimum BMI of 18 kilograms per meter squared (kg/m2) at Screening.
Who cannot join
- Historical or current evidence of a clinically significant disease or disorder.
- Participants with a known hypersensitivity to AZD5462 or dapagliflozin, or to any of the excipients of these drug products.
- Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication.
- Cardiac ventricular arrhythmia that requires treatment. However, participants with atrial fibrillation or flutter and controlled ventricular rate (eg, resting heart rate < 110 beats per minute) are permitted. Participants with cardiac ventricular arrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and are stable are permitted.
- History of or anticipated heart transplant.
- Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, valve repair/replacement, aortic aneurysm surgery).
- Any evidence of clinically important disease or disorder which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
- Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis B virus core antibody at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.
Read the detailed description
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety, pharmacodynamics, and pharmacokinetics of AZD5462 on top of dapagliflozin in participants with heart failure and renal impairment.
The study will include 5 periods and approximately 9 study site visits:
- Screening Period of up to 4 weeks (at least one study visit)
- Run-in Period of up to 4 weeks (one study visit)
- Inpatient Treatment Period of 4 days (one study visit)
- Outpatient Treatment Period of up to 4 weeks (three study visits)
- Follow-up Period of up to 4 weeks (three study visits)
- Conditions
- Renal Impairment, Heart Failure
- Being tested
- AZD5462, Dapagliflozin, Placebo
- Keywords
- Relaxin family peptide receptor 1 agonist, Estimated glomerular filtration rate, Heart failure, Renal impairment
- Medical subject headings
- Renal Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5462Drug
Participants will receive AZD5462 on top of dapagliflozin once daily.
DapagliflozinDrug
Participants will receive dapagliflozin once daily with AZD5462 or placebo.
PlaceboOther
Participants will receive placebo on top of dapagliflozin once daily.
| Study group | Role | What they receive |
|---|---|---|
| AZD5462 + dapagliflozin | Active comparator | Participants will receive AZD5462 on top of dapagliflozin once daily. Receives: Drug: AZD5462; Drug: Dapagliflozin |
| Placebo + dapagliflozin | Placebo comparator | Participants will receive placebo on top of dapagliflozin once daily. Receives: Drug: Dapagliflozin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sodium excretion
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with heart failure (HF) and renal impairment.
Measured: From Baseline to Day 1
Secondary outcomes (3)
Change in urine albumin-creatinine ratio (uACR)
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with HF and renal impairment.
Measured: From Baseline to Day 1 and 29
Change in haematocrit
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with HF and renal impairment.
Measured: From Baseline to Day 29
Number of adverse events (AEs) and Serious Adverse Events (SAEs)
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with HF and renal impairment.
Measured: From Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start27 Sep 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639087
- Sponsor's protocol ID
- D9090C00007
- Other IDs
- 2024-513142-11-00
- Acronym
- AURORA
- Status last verified
- Sep 2025
- First submitted
- 13 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 Vivli.org. 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
- Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
- ClinicalTrials.gov ID
- NCT06639087
- Acronym / sponsor ID
- AURORA / D9090C00007
- Conditions
- Renal Impairment, Heart Failure
- Keywords
- Relaxin family peptide receptor 1 agonist, Estimated glomerular filtration rate, Heart failure, Renal impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 15 Oct 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.
A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety, pharmacodynamics, and pharmacokinetics of AZD5462 on top of dapagliflozin in participants with heart failure and renal impairment.
The study will include 5 periods and approximately 9 study site visits:
- Screening Period of up to 4 weeks (at least one study visit)
- Run-in Period of up to 4 weeks (one study visit)
- Inpatient Treatment Period of 4 days (one study visit)
- Outpatient Treatment Period of up to 4 weeks (three study visits)
- Follow-up Period of up to 4 weeks (three study visits)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD5462 + dapagliflozin | Active comparator | Drug: AZD5462, Drug: DapagliflozinParticipants will receive AZD5462 on top of dapagliflozin once daily. |
| Placebo + dapagliflozin | Placebo comparator | Drug: Dapagliflozin, Other: PlaceboParticipants will receive placebo on top of dapagliflozin once daily. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have a pre-existing diagnosis of heart failure (HF).
- Participants must have a left ventricular ejection fraction (LVEF) of ≤ 40% based on echocardiography taken within the last 9 months.
- Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) at Screening as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 (creatinine) equation.
- Participants must be on stable HF standard of care (SoC) medication for at least 4 weeks prior to Screening. If the participant is currently taking diuretics, then diuretics must also be stable for at least one week prior to Screening.
- Participants must be on stable Sodium-glucose co-transporter-2 inhibitors (SGLT2) inhibitor treatment for at least 12 weeks prior to Screening.
Key exclusion criteria (8 listed)
- Historical or current evidence of a clinically significant disease or disorder.
- Participants with a known hypersensitivity to AZD5462 or dapagliflozin, or to any of the excipients of these drug products.
- Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication.
- Cardiac ventricular arrhythmia that requires treatment. However, participants with atrial fibrillation or flutter and controlled ventricular rate (eg, resting heart rate < 110 beats per minute) are permitted. Participants with cardiac ventricular arrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and are stable are permitted.
- History of or anticipated heart transplant.
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 |
|---|---|---|
| AZD5462Participants will receive AZD5462 on top of dapagliflozin once daily. | Drug | AZD5462 + dapagliflozin |
| DapagliflozinParticipants will receive dapagliflozin once daily with AZD5462 or placebo. | Drug | AZD5462 + dapagliflozin, Placebo + dapagliflozin |
| PlaceboParticipants will receive placebo on top of dapagliflozin once daily. | Other | Placebo + dapagliflozin |
Primary outcome
Change in sodium excretion
Time frame: From Baseline to Day 1
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with heart failure (HF) and renal impairment.
3 secondary outcomes
Change in urine albumin-creatinine ratio (uACR)
Time frame: From Baseline to Day 1 and 29
Change in haematocrit
Time frame: From Baseline to Day 29
Number of adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline to Day 57
Results and safety
The study was stopped early (reason given: Sponsor Decision). 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 Vivli.org. 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.
The record lists no contact. Use the official record to reach the sponsor.
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 AZD5462 and Dapagliflozin in people with Renal Impairment and Heart Failure, run by AstraZeneca at 1 site in Bulgaria.
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 6 inclusion and 8 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 Bulgaria. 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: Sponsor Decision). 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?
Change in sodium excretion (time frame: From Baseline to Day 1). 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.