Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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

This research study is testing a new medication, AZD5462. It's being given alongside an existing medication, Dapagliflozin, to people who have both heart failure and moderate kidney impairment. The main goal is to find out if AZD5462 is safe to use and whether it has any helpful effects for these conditions. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in people. Participants will be randomly assigned to either receive AZD5462 or a dummy treatment (placebo) alongside their Dapagliflozin, and neither they nor their doctors will know which they are getting. This helps ensure the results are fair and accurate.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

10 Sep 2024

Moderate Renal Impairment Heart Failure

What is this study about?

This research is focused on people who have two medical conditions: heart failure and moderate kidney impairment. Heart failure means your heart isn't pumping blood as well as it should, which can cause symptoms like breathlessness and tiredness. Moderate kidney impairment means your kidneys, which filter waste from your blood, aren't working quite as efficiently as they should.

The study is looking at a new medicine called AZD5462. This new medicine will be given in addition to an existing medicine called Dapagliflozin, which is already used to treat conditions like heart failure. The main purpose of this early study is to see if AZD5462 is safe for people to take when they have these conditions, and to see what effects it has on their body.

Because this is an early study, researchers are carefully checking for any side effects and trying to understand how this new medicine works in people. Participants will be randomly given either the new medicine or a dummy treatment (placebo) alongside their Dapagliflozin. This is done so that researchers can fairly compare the effects of the new medicine against not having it, without anyone knowing who is getting what. This helps doctors learn if AZD5462 could be a helpful future treatment option.

Key takeaways

This study is testing a new medicine (AZD5462) for heart failure and kidney problems.
It's an early-stage study to check safety and initial effects.
Participants will also take Dapagliflozin, an existing medicine.
You'll be randomly assigned to receive AZD5462 or a dummy treatment.
Regular clinic visits and health checks will be part of the study.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Crucially, you must have been diagnosed with both heart failure and moderate kidney impairment. There will be specific medical tests done to confirm that your kidney function fits the 'moderate impairment' criteria for the study.

The research team will need to check your full medical history and current health to make sure this study is right and safe for you. They will have detailed rules about other conditions or medicines that might mean you can't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with heart failure?
Do you have a diagnosis of moderate kidney impairment?
Are you currently taking Dapagliflozin, or would you be eligible to take it?
Are you willing to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups: either receiving the new medicine (AZD5462) or a dummy treatment (placebo). Both groups will also continue to take Dapagliflozin. Neither you nor your study doctor will know which group you are in, which helps keep the results unbiased.

Taking part will involve regular visits to a clinic for health checks, blood tests, and perhaps other assessments to see how the medicine is affecting you. You will also need to take the study medication as instructed. There will be follow-up appointments after you stop taking the study medicine to ensure your safety. The total time you would be involved in the study, from start to finish, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in a study like this might offer some potential benefits, such as contributing to medical knowledge that could help future patients with heart failure and kidney problems. You would also receive close medical attention and monitoring. However, there's no guarantee the new medicine will directly benefit you, and you might experience side effects. It's important to weigh these up carefully. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Bulgaria
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Unverified
Sweden

Common questions

What is 'heart failure' and 'moderate kidney impairment'?

Heart failure means your heart isn't pumping blood as well as it should. Moderate kidney impairment means your kidneys aren't filtering waste from your blood as efficiently as they could be.

What does 'randomised' mean in this study?

It means you will be put into a group by chance – like flipping a coin – to either receive the new medicine or a dummy treatment, alongside your usual medication.

What does 'double-blind' mean?

This means that neither you nor your study doctor will know whether you are receiving the new medicine or the dummy treatment. This helps make the study fair.

Will I still take my regular heart or kidney medicines?

The study involves taking the new medicine (or placebo) in addition to Dapagliflozin. Your study team will discuss all your current medications with you.

What if I feel unwell during the study?

You will have regular contact with the study team. You should always tell them immediately if you experience any new symptoms or feel unwell while taking part.