RecruitingPHASE3INTERVENTIONAL

Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)

The IMPEDE-PKD study is investigating if a common diabetes medication called metformin could help people with a specific kidney condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD causes cysts to grow in the kidneys, leading to a decline in kidney function over time. Researchers want to see if metformin can slow this decline, improve overall health, and increase quality of life. Currently, treatment options are limited and can have side effects or be expensive. Metformin is an affordable and well-known drug that has shown promise in earlier studies by targeting the way these cysts grow. This large, international study hopes to find a new, effective treatment for ADPKD.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

The University of Queensland

Enrolment target

1,174

Start

29 Nov 2022

Estimated completion

01 Dec 2030

Autosomal Dominant Polycystic Kidney Disease

What is this study about?

This study, called IMPEDE-PKD, is looking into a new way to help people with a condition called Autosomal Dominant Polycystic Kidney Disease, or ADPKD. ADPKD is a genetic condition where fluid-filled sacs, called cysts, grow in the kidneys. Over time, these cysts can get bigger and lead to pain, high blood pressure, and eventually, the kidneys not working as well as they should. ADPKD affects many people worldwide and can also lead to other health issues like anxiety and depression.

Currently, there aren't many widely available and affordable treatments for ADPKD. There is one medication approved, but it can have side effects and be expensive. This is where the medication metformin comes in. Metformin is already widely used and trusted to treat type 2 diabetes. However, earlier research has suggested that it might also have properties that could slow down the growth of these kidney cysts in people with ADPKD. If successful, metformin could become a much-needed, affordable, and effective treatment.

This study aims to find out if taking metformin can slow down how quickly kidney function declines in people with ADPKD. If it works, it could significantly reduce serious health problems, improve how long people live, and greatly boost their quality of life. This is a large, international study, and the results could make a big difference for many families affected by ADPKD.

Key takeaways

The study explores if metformin can slow ADPKD progression.
ADPKD is a genetic kidney disease causing cysts.
Metformin is a common, affordable diabetes drug being re-purposed.
The goal is to improve quality of life and reduce health problems for ADPKD patients.
Participants will be randomly assigned to metformin or a placebo.
This is a large, international study that could lead to new treatments.

Who may be eligible?

In general, this study is looking for adults aged 18 to 70 who have been diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Your kidneys need to be working within a certain range – not too healthy, but not too far along in the disease – to be considered. The doctors will also look at whether your ADPKD shows signs of progressing, either because your kidneys are a certain size, or if your kidney function has been declining over time. They will use specific measurements to figure this out.

However, you won't be able to join if you have diabetes, very high blood pressure that isn't under control, certain serious heart problems, or some types of liver disease. Your doctor will be able to check all these details to see if this study could be right for you.

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 70 years old?
Have you been diagnosed with ADPKD?
Do you have a certain level of kidney function (not too early, not too late stage)?
Are there signs that your ADPKD is progressing, or are your kidneys a certain size?
Do you have diabetes, uncontrolled high blood pressure, or significant heart or liver disease (which would exclude you)?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would be randomly assigned to either receive the study medication (metformin) or a placebo (a dummy pill that looks like the real medication but has no active ingredients). This is to fairly compare if metformin is effective. You will have regular visits to the clinic for check-ups, blood tests, and scans to monitor your kidney function and overall health. You'll need to take the study medication as instructed. The total duration of your participation in the study, including all follow-up appointments, will be explained by the study team, but typically clinical trials involve multiple visits over several years.

Potential risks and benefits

Participating in this study might offer the potential benefit of slowing down the progression of your kidney disease, which could improve your long-term health and quality of life. However, as with any medication, there's a possibility of side effects from metformin, which the study team will explain in detail. There's also the chance the treatment might not be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (49)

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

Renal Research
Verified postcode
Gosford, Australia· Active not recruiting
Royal Prince Alfred Hospital
Verified postcode
Sydney, Australia· Active not recruiting
Royal North Shore Hospital
Verified postcode
Sydney, Australia· Active not recruiting
Westmead Hospital - Western Sydney Local Health District
Verified postcode
Sydney, Australia· Active not recruiting
Bundaberg Hospital
Verified postcode
Bundaberg, Australia· Active not recruiting
Townsville University Hospital
Verified postcode
Douglas, Australia· Active not recruiting
Royal Brisbane and Women's Hospital
Verified postcode
Herston, Australia· Active not recruiting
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia· Active not recruiting
Royal Adelaide Hospital
Verified postcode
Adelaide, Australia· Active not recruiting
Royal Melbourne Hospital
Verified postcode
Melbourne, Australia· Active not recruiting
Austin Health
Verified postcode
Melbourne, Australia· Active not recruiting
Monash Medical Centre
Verified postcode
Melbourne, Australia· Active not 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 your kidneys, which can make them less effective over time.

What is metformin?

Metformin is a common and affordable medication primarily used to treat type 2 diabetes. This study wants to see if it can also help people with ADPKD.

Will I definitely get metformin if I join?

No, you might receive metformin or a placebo (a dummy pill) as part of a randomised study. This helps researchers fairly compare its effects.

How long will the study last?

The study will involve regular visits and taking medication over a period that will be explained to you by the study team. Clinical trials often last several years.

Can I stop being part of the study whenever I want?

Yes, you can choose to leave the study at any time, for any reason. Your decision won't affect your regular medical care.

How to find out more

Misa Matsuyama, PhD

impedepkd@uq.edu.au +61 437 759 894 Official trial record

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