At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Metformin XR (drug), Control (other)
- How long the study runs
- Study runs about 97 months (dates as stated)
- About the drug or intervention
- Metformin XR — drug: Extended release metformin. · Control — other: Placebo is inactive tablets that is identical to the intervention Metformin tablets.
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial, run by The University of Queensland, is testing whether metformin (a common medicine) can help slow the decline of kidney function in adults with autosomal dominant polycystic kidney disease (ADPKD), a condition where fluid-filled cysts grow in the kidneys.
Who can take part
- Adults aged 18 to 70 who are willing and able to give informed consent
- A diagnosis of ADPKD based on scans and/or genetic tests, using set guidelines
- Kidney function (eGFR) between 38 and below 90 mL/min/1.73m2
- Signs the disease may get worse, such as large kidneys, a high risk score, or kidney function that is already dropping over time
- If taking tolvaptan, the dose must have been stable for at least 3 months and started at least 6 months ago
Who may not be able to
- People with diabetes or other conditions (other than high blood pressure) that can cause kidney disease
- Uncontrolled high blood pressure
- Significant heart failure
- Certain liver problems, including very high liver enzymes or poor liver function scores
- Any reason metformin cannot be taken, such as abnormal liver tests or untreated vitamin B12 deficiency
- Already taking metformin
- Pregnancy, breastfeeding, or planning pregnancy in the next three years
- Certain other health problems, such as active cancer, previous solid organ transplant, active lung disease (COPD), active inflammatory bowel disease, or a stoma
- Previous dialysis
What taking part involves
- • Taking metformin — Not stated — ask the trial team about the dose and how it is given
Time commitment: Not stated — ask the trial team about how long the trial lasts, how many visits are needed, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 1,174
- Started
- 2022-11-29
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for autosomal dominant polycystic kidney disease
- • Phase3 - 1,174 participants
- • This study will investigate if a medication (metformin) widely used in the treatment of diabetes could be re-purposed for the treatment of patients with a diagnosis of early stage ADPKD to slow the rate of kidney function decline, reducing morbidity and mortality and improving the quality of life for ADPKD patients
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with autosomal dominant polycystic kidney disease
Where?
- • Exeter - Royal Devon & Exeter Hospital
- • Nottingham - Nottingham Renal Unit, Nottingham City Hospital
- • Inverness - Raigmore Hospital
- • Preston - Royal Preston Hospital
- • +27 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will investigate if a medication (metformin) widely used in the treatment of diabetes could be re-purposed for the treatment of patients with a diagnosis of early stage ADPKD to slow the rate of kidney function decline, reducing morbidity and mortality and improving the quality of life for ADPKD patients.
More detail
Autosomal Dominant Polycystic Kidney Disease (ADPKD) affects 12.5 million people worldwide and is the 4th leading cause of kidney failure. Cyst growth begins in childhood, and over decades leads to painful kidneys, hypertension and chronic kidney disease. ADPKD patients also have a high prevalence of anxiety, depression and poor quality of life. Despite this enormous burden, there is a lack of evidence for therapies and affordable, effective treatment options. To date, only one disease modifying therapy is licensed for use in ADPKD (tolvaptan), but it is limited by its restricted availability, side effects and high cost. Metformin, an inexpensive and familiar drug, has been shown in previous studies to target cyst-forming signals, thereby slowing the cyst growth rate. IMPEDE-PKD is an Australian-led global Phase III randomised controlled trial to investigate the effect of metformin on ADPKD disease progression. The study will recruit a total of 1,174 adult ADPKD patients from around the world (250 from Australia). The outcomes of this research will identify effective and targeted therapies for ADPKD that will slow kidney function decline, reduce the impact of the illness and likelihood of death, and improve the quality of life for ADPKD patients and families.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ been in place for at least 6 months with stable dose for at least 3 months
What the study is looking for
- ✓To be eligible to participate in this trial, patients must satisfy all of the following inclusion criteria:
- ✓Willing to participate and provide agreement to take part
- ✓Aged 18-70 years
- ✓Diagnosis of ADPKD based on radiological +/- genetic criteria as per Kidney Health Australia - Caring for...
- ✓eGFR equal to or greater than 38 mL/min/1.73m2 and \<90 mL/min/1.73m2
Who cannot take part
- ✗Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD...
- ✗Uncontrolled hypertension (Systolic BP \>160 mmHg and/or diastolic BP \>100 mmHg after a period of rest)
- ✗Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV
- ✗Non-polycystic liver disease, including but not limited to:
- ✗Liver enzymes (liver enzymes, liver enzymes or Total liver blood test) \>2 times the upper limit of normal, except when a diagnosis of Gilbert...
See the full criteria
Where Is This Study? (31 UK sites)
Royal Devon & Exeter Hospital
Exeter EX2 5DW, United Kingdom
Nottingham Renal Unit, Nottingham City Hospital
Nottingham NG5 1PB, United Kingdom
Raigmore Hospital
Inverness IV2 3UJ, United Kingdom
Royal Preston Hospital
Preston PR2 9HT, United Kingdom
Salford Royal Hospital
Salford M6 8HD, United Kingdom
Leicester General Hospital
Leicester LE5 4PW, United Kingdom
St Helier Hospital
Carshalton SM5 1AA, United Kingdom
Aintree University Hospital
Liverpool L9 7AL, United Kingdom
Norfolk and Norwich University Hospital
Norwich NR4 7UY, United Kingdom
Antrim Area Hospital
Antrim BT41 2RL, United Kingdom
Ulster Hospital
Belfast BT16 1RH, United Kingdom
Altnagelvin Hospital
Londonderry BT47 6SB, United Kingdom
Daisy Hill Hospital
Newry BT35 8DR, United Kingdom
Oxford Kidney Unit, Churchill Hospital,
Oxford OX3 7LE, United Kingdom
Doncaster Royal Infirmary
Doncaster DN2 5LT, United Kingdom
Sheffield Kidney Institute
Sheffield S5 7AU, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham B15 2GW, United Kingdom
Bradford Renal Unit, St Luke's Hospital
Bradford BD5 0NA, United Kingdom
Cardiff and Vale University Health Board
Cardiff, United Kingdom
Epsom and St Helier University Hospitals
Carshalton, United Kingdom
The Royal London Hospital
London E1 1FR, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
St George's University Hospital
London, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
East & North Hertfordshire Teaching NHS Trust
Stevenage, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069South Tyneside and Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Research and Development stsft.research@nhs.net
stsft.research@nhs.net0191 565 6256 ext 42143York and Scarborough Teacehing Hospitals
York, United Kingdom
How to Get in Touch
Misa Matsuyama, PhD
Sponsor contactCONTACT
Pushparaj Velayudham
Sponsor contactCONTACT
