Implementation of Metformin theraPy to Ease DEcline of kidney function in PKD (IMPEDE-PKD)
Principal Investigators: Professor Andrew Mallett
Clinical Project Manager: Pushparaj Velayudham
Clinical Research Associate: Misa Matsuyama
Trial Number: AKTN 16.01
ClinicalTrials.gov registration page: IMPEDE-PKD page
Population: Aged 18-70 years with confirmed diagnosis of APDKD with eGFR between 38-89 mL/min/1.73m2, with either risk factors of progression or evidence of active progression. Those on tolvaptan must have been on therapy for at least 6 months, with a stable dose for at least 3 months.
Intervention: The IMPEDE-PKD trial is studying whether a drug called metformin can slow down the rate at which kidney disease progresses in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Primary outcome: To evaluate the long-term efficacy of metformin therapy compared to placebo in slowing the rate of kidney function decline in adults with autosomal-dominant polycystic kidney disease (ADPKD).
Status: Recruitment open
Target Recruitment: 1,174 participants globally (Samoa, Fiji, and Thailand)
Trial Summary
Autosomal Dominant Polycystic Kidney Disease (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 the 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.
The IMPEDE-PKD trial is a prospective, multicentre, double blind randomised controlled trial. Study participants are randomised to receive either metformin or a placebo (inactive pill). All study participants receive standard care and complete some trial questionnaires and blood and urine tests. 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.
The IMPEDE-PKD trial is an international trial, including Australia, New Zealand, United Kingdom, Europe, India and North America. Australia was the first country to start the IMPEDE-PKD trial and has completed its recruitment phase, thanks to many hospitals across the country. Australian participants are now in the follow-up phase of the trial.
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
“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
“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
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