RecruitingPHASE2INTERVENTIONAL

Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease

This research study is investigating a new medication called AZD2373 for people who have a particular genetic form of kidney disease, known as APOL1-Mediated Kidney Disease (AMKD). The main goal is to find out if AZD2373 can help reduce kidney damage, specifically by looking at a protein level in urine (UACR), and to make sure the drug is safe. Participants will be aged 18 to 65 and have the specific genetic markers for AMKD. They will be split into different groups, some receiving the new drug and others a dummy treatment (placebo), without knowing which they are on. The study involves taking treatment for at least 30 weeks.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

Start

05 Mar 2025

Estimated completion

30 Aug 2027

APOL1-Mediated Kidney Disease

What is this study about?

This study is about a new medicine called AZD2373, designed for people with a specific type of kidney problem known as APOL1-Mediated Kidney Disease, or AMKD. This condition is linked to changes in a gene called APOL1. Researchers want to see if AZD2373 can help people with AMKD by reducing the amount of a protein found in their urine (called UACR). A high level of this protein can be a sign that the kidneys are not working as well as they should.

The main aim is to see how effective AZD2373 is compared to a 'dummy' drug (placebo) and to track any side effects to make sure it's safe. Finding better treatments for kidney diseases like AMKD is very important because these conditions can worsen over time and sometimes lead to serious health problems. This study is an important step in potentially offering new options for patients.

Everyone involved, including the patients and the medical staff, won't know who is getting the real drug and who is getting the placebo. This helps make sure the results are fair and accurate. The study will look closely at changes in kidney health over a period of at least 30 weeks to understand the drug's effects.

Key takeaways

Tests new drug AZD2373 for APOL1-related kidney disease.
Compares AZD2373 to a placebo (dummy treatment).
Aims to check safety and how well it lowers urine protein.
Requires participants aged 18-65 with specific genetic markers.
Involves at least 30 weeks of treatment and regular health checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be between 18 and 65 years old and have been diagnosed with APOL1-Mediated Kidney Disease. This means you must have specific high-risk changes in your APOL1 genes (G1/G1, G1/G2, or G2/G2). Your kidney function will also be checked: your urine protein level (UACR) should be 300 mg/g or higher, and your kidney filtering rate (eGFR) should be at least 25 mL/min/1.73m2.

There are also some reasons why you might not be able to join. For example, if you already have kidney replacement therapy like dialysis or a kidney transplant, or if you've had other organ transplants, you can't take part. People with Type 1 diabetes, very high blood pressure or BMI, or certain heart conditions will also be excluded. If you have Type 2 diabetes, there are additional specific criteria related to your insulin use and blood sugar levels that would prevent you from joining.

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 APOL1-Mediated Kidney Disease with specific genetic changes?
Is your kidney function (eGFR) at least 25 mL/min/1.73m2?
Is your urine protein level (UACR) 300 mg/g or higher?
Do you currently have a kidney transplant or are on dialysis? (If yes, you likely can't join.)
Do you have uncontrolled high blood pressure or certain heart conditions? (If yes, you likely can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of three groups by chance. Two groups will receive different doses of the new drug AZD2373, and one group will receive a placebo (a dummy treatment with no active drug). Neither you nor your study doctor will know which treatment you are receiving. You will take the study treatment for at least 30 weeks.

Throughout the study, you will have regular visits to the clinic for various assessments. These will include blood tests, urine tests to check your kidney function (like UACR), blood pressure measurements, and other health checks to monitor your progress and safety. The total duration of your active treatment in the study will be at least 30 weeks, and you will stay on treatment until the last participant completes this period.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new experimental treatment for APOL1-Mediated Kidney Disease that isn't yet available. However, there's no guarantee that the treatment will help everyone, and you might receive a placebo. Like all medicines, AZD2373 could have side effects, and these will be carefully monitored throughout the study. You will be informed of any known or potential risks. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (77)

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

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Alabaster, United States· Recruiting
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Birmingham, United States· Recruiting
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Irondale, United States· Recruiting
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Beverly Hills, United States· Recruiting
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Gardena, United States· Recruiting
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Los Angeles, United States· Not yet recruiting
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Valencia, United States· Recruiting
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Brandon, United States· Recruiting
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Miami, United States· Recruiting
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Miami, United States· Recruiting
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Orlando, United States· Recruiting
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Pompano Beach, United States· Recruiting

Common questions

What is APOL1-Mediated Kidney Disease?

It's a type of kidney disease linked to specific genetic changes in the APOL1 gene, which can make your kidneys less able to clean your blood over time.

What is AZD2373?

AZD2373 is a new medicine being tested to see if it can help improve kidney function for people with APOL1-Mediated Kidney Disease.

What does 'placebo' mean?

A placebo is a 'dummy' pill or treatment that looks like the active drug but doesn't contain any medicine. It's used to compare the real drug's effects.

How long will I be in the study?

You'll be taking the study treatment for at least 30 weeks, and the full study might run for longer depending on when the last person finishes.

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

No, neither you nor your doctor will know which treatment you are receiving. This is common practice in clinical trials for fair results.

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.