RecruitingPHASE1INTERVENTIONAL

Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease

This research is testing a new medicine, AZD1613, for adults living with a condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD). The main goal is to understand if the medicine is safe and well-tolerated when given either through an injection under the skin or into a vein. Researchers will also look at how the body processes the medicine. Some participants will receive a dummy medicine (placebo) for comparison. The study involves a small group of people in its early stages to learn as much as possible about safety before moving to larger studies.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

10 Nov 2025

Estimated completion

26 Jan 2027

Autosomal Dominant Polycystic Kidney Disease

What is this study about?

This study is an early-stage clinical trial looking into a new medicine called AZD1613. It's designed for adults who have a specific kidney condition known as Autosomal Dominant Polycystic Kidney Disease, or ADPKD. ADPKD causes fluid-filled sacs, called cysts, to grow in the kidneys, which can eventually affect how well the kidneys work.

The main purpose of this study is to find out if AZD1613 is safe to use and how well people tolerate it. This means keeping a close eye on any side effects that might occur. The researchers also want to understand how your body handles the medicine – how it's absorbed, distributed, and removed. Knowing these details helps them work out the best way to give the medicine and the right amount to use.

In this study, some people will receive the new medicine, while others will get a 'placebo', which is a dummy medicine that looks just like the real thing but doesn't contain any active drug. This comparison helps researchers clearly see the effects of AZD1613. The study also aims to see if the medicine works differently in people of Chinese background.

Key takeaways

This is an early-stage study for a new ADPKD medicine (AZD1613).
It aims to check the medicine's safety and how the body handles it.
Some participants will receive a dummy medicine (placebo) for comparison.
People aged 18-65 with ADPKD and specific kidney function can join.
Your health will be closely monitored with regular tests like blood tests and ECGs.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and have been diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Your kidney function, measured by something called eGFR, should be within a specific range (45 to 90 mL/min/1.73m2). Your weight and body mass index (BMI) also need to be within certain limits.

There are also some important reasons why you might not be able to join. For instance, if you have certain heart conditions, uncontrolled high blood pressure, or other serious medical problems, the study might not be suitable for you. This includes if you've had a history of certain heart rhythm issues or if you have infections like Hepatitis B, Hepatitis C, or HIV.

They will also check your blood test results and a heart tracing (ECG) to make sure you are healthy enough for the study. If you are female, you must not be able to become pregnant.

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 between 18 and 65 years old?
Have you been diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD)?
Do you have good overall health, without serious heart problems or uncontrolled blood pressure?
If you are female, are you unable to become pregnant?
Are you prepared for regular hospital visits and health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, AZD1613, or a placebo. This medicine will be given either as an injection under your skin or directly into a vein. During the study, you will have regular visits to the clinic where the study team will monitor your health very closely. These visits will involve various tests, such as blood tests, heart tracings (ECGs), and checks of your blood pressure and other vital signs.

The study team will assess if you experience any side effects and how your body reacts to the medicine. The total duration of your participation in the study, including the treatment period and follow-up, will be explained in detail by the study team. You'll be asked to follow specific instructions regarding your medication and any other treatments you're receiving.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. While there's no guarantee you'll directly benefit, your participation could help researchers learn more about ADPKD and potentially lead to new treatments. However, there's a risk of experiencing side effects from the study medicine, or even from the tests and procedures involved. These will be explained in full detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

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

Research Site
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Birmingham, United States· Not yet recruiting
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Loma Linda, United States· Not yet recruiting
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Jacksonville, United States· Recruiting
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Orlando, United States· Recruiting
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Lenexa, United States· Recruiting
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Baltimore, United States· Not yet recruiting
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Rochester, United States· Recruiting
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San Antonio, United States· Not yet recruiting
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Chengdu, China· Not yet recruiting
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Hangzhou, China· Not yet recruiting
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Nanjing, China· Not yet recruiting
Research Site
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Shanghai, China· Not yet recruiting

Common questions

What is ADPKD?

ADPKD stands for Autosomal Dominant Polycystic Kidney Disease. It's a genetic condition where fluid-filled sacs, called cysts, grow in the kidneys, which can cause them to work less well over time.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active drug. It's used to compare the effects of the new medicine to see if it's truly making a difference.

Will I know if I'm getting the real medicine or the placebo?

In this type of study, you usually won't know whether you are receiving the real medicine or a placebo. This is to ensure fair and accurate results.

What does 'pharmacokinetics' mean?

Pharmacokinetics is about how your body handles the medicine – how it's absorbed into your bloodstream, moves around your body, gets changed, and is finally removed.

How long will I be involved in the study?

The exact duration of your involvement will be explained by the study team. It includes the period you receive the medicine and any follow-up visits.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.