Implementation of Metformin theraPy to Ease DEcline of kidney function in PKD (IMPEDE-PKD)

The IMPEDE-PKD trial will study if a drug called metformin can slow down the rate at which kidney disease progresses in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD is the 4th most common reason for starting dialysis in Australia. But there is a lack of affordable and effective treatment options for people with ADPKD. Metformin is not a new drug, it has been used to treat patients with diabetes for many years and is also used for treatment of polycystic ovarian syndrome. Animal studies have shown that metformin could change how ADPKD disease progresses. Recent clinical studies in people with ADPKD have shown that metformin is safe to use in people with ADPKD. This is the first clinical study to test if metformin therapy is effective in treating people with ADPKD. If successful, this study could change the future clinical care of people with ADPKD.

Diabetes drug could prevent kidney failure (UQ News, July 2020).

In this trial we are evaluating the potential efficacy and role of a common and repurposed medicine, Metformin, in slowing the loss of kidney function in the most common genetic kidney disease – Autosomal Dominant Polycystic Kidney Disease. It has been designed and led by a group of passionate clinicians, researchers and patients over the past several years and involves leading global experts in ADPKD. At the end of the trial and in conjunction with our international partners, we aim to generate data which helps us to more definitely understand whether an effective treatment for ADPKD might already be within reach. Further, our partnership across stakeholders will realise opportunities to ensure rapid translation of those findings, both into practice and future research seeking to improve the lives of those affected by ADPKD.

Professor Andrew Mallett, Coordinating Principal Investigator
What does the IMPEDE-PKD trial involve for participants?

The IMPEDE-PKD trial is a prospective, multicentre, double blind randomised controlled trial. Study participants will be randomised to receive either metformin or a placebo (inactive pill). All study participants will receive standard care and complete some trial questionnaires and blood and urine tests.

“Any safe drug that can slow the progression of kidney cysts and decline is a major win for PKD patients. Especially if the drug is effective enough to prevent having to endure a kidney transplant and the life-long use of immunosuppressant anti rejection medication.”

PKD Consumer
How will the IMPEDE-PKD trial outcome be measured?

The IMPEDE-PKD trial will look at changes in study participants’ estimated Glomerular Filtration Rate (eGFR). eGFR measures how well kidneys can filter toxins or waste from blood. A lower eGFR means a reduction in kidney function. This is measured through a routine blood test.

Where is the IMPEDE-PKD trial going to be conducted?

The IMPEDE-PKD trial is an international trial, including Australia, New Zealand, United Kingdom, Europe, India and North America. Australia will be the first country to start the IMPEDE-PKD trial. The trial will be conducted at hospitals across Australia.

When is the IMPEDE-PKD trial starting?

The trial will start at the following sites in Australia in 2022:
NSW – Westmead Hospital
QLD – Princess Alexandra Hospital 

The trial will start at the following sites in Australia in 2023:
QLD – Royal Brisbane & Women’s Hospital
QLD – Townsville University Hospital 
QLD – Bundaberg Hospital 
SA – Royal Adelaide Hospital 
NSW – Gosford Renal Research
NSW – Royal North Shore Hospital 
NSW – Royal Prince Alfred Hospital 
VIC – Austin Hospital
VIC – Monash Health 
WA – Sir Charles Gairdner Hospital

Who can take part in the IMPEDE-PKD trial?

Adults with ADPKD aged 18 to 70 years who meet the study eligibility criteria.

Study team and funding:

Professor Andrew Mallett (the University of Queensland) is the Coordinating Principal Investigator.

Pushparaj Velayudham is the Clinical Project Manager and Misa Matsuyama is the Clinical Research Associate.

The Medical Research Future Fund (Australian government) is funding this research.

Trial Number: AKTN 16.01

“IMPEDE-PKD is a really important trial that will prove whether the cheap, safe and already available medication, metformin, is effective at slowing kidney function loss and painful kidney cyst growth in people with ADPKD. It offers hope to the many people and families affected by this profoundly painful, progressive and perilous disease that currently has limited treatment options.”

Professor David Johnson, Deputy Chair AKTN