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Looking for participantsPhase3

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

Sponsor: The University of Queensland

NCT ID: NCT04939935

View on ClinicalTrials.gov ↗

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.

Autosomal Dominant Polycystic Kidney Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

eGFR

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
Inclusion Criteria: To be eligible to participate in this trial, patients must satisfy all of the following inclusion criteria: 1. Willing to participate and provide informed consent 2. Aged 18-70 years 3. Diagnosis of ADPKD based on radiological +/- genetic criteria as per Kidney Health Australia - Caring for Australians and New Zealanders with Kidney Impairment (KHA-CARI) Guidelines 4. eGFR equal to or greater than 38 mL/min/1.73m2 and \<90 mL/min/1.73m2 And have either: 5(a) One or more risk factors of progression from the following: * Bilateral kidney length equal to or greater than16.5 cm, or * Total Kidney Volume (TKV) equal to or greater than 750 mL or height-adjusted TKV (htTKV) equal to or greater than 600 mL/m2, or * Mayo class IC/D/E or Pro-PKD score equal to or greater than 6 OR 5(b) Evidence of Active progression * Decline in eGFR equal to or greater than 5 mL/min/1.73m2 in one year, or * Decline in eGFR equal to or greater than 3 mL/min/1.73m2 per year over five years or more. or * Increase in htTKV/TKV of equal to or greater than 5% per year on at least 2 measurements in the past year, excluding any initial eGFR effect over the initial 3 months of tolvaptan commencement (if applicable) Note: Tolvaptan therapy must have been in place for at least 6 months with stable dose for at least 3 months. Exclusion Criteria: 1. Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD independent of PKD (excluding hypertension) 2. Uncontrolled hypertension (Systolic BP \>160 mmHg and/or diastolic BP \>100 mmHg after a period of rest) 3. Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV 4. Non-polycystic liver disease, including but not limited to: 1. Liver enzymes (ALT, AST or Total Bilirubin) \>2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists and/or, 2. Child-Pugh classification score equal to or greater than 5 5. Any contraindication to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency 6. Currently taking metformin 7. Pregnancy or breastfeeding, or planning to get pregnant in the next three years. 8. Comorbidities with potential to contaminate trial outcomes, specifically active cancer, history of other solid organ transplantations, active chronic obstructive pulmonary disease (COPD), active inflammatory bowel disease, and the presence of stoma. 9. History of dialysis.

Where Is This Study? (31 UK sites)

Royal Devon & Exeter Hospital

Exeter EX2 5DW, United Kingdom

Recruiting
Site contact (verified)
Rhian Clissold, DrPrincipal Investigator

Nottingham Renal Unit, Nottingham City Hospital

Nottingham NG5 1PB, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Matt Hall, DrPrincipal Investigator

Raigmore Hospital

Inverness IV2 3UJ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Stewart Lambie, DrPrincipal Investigator

Royal Preston Hospital

Preston PR2 9HT, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Aimun Ahmed, DrPrincipal Investigator

Salford Royal Hospital

Salford M6 8HD, United Kingdom

Recruiting
Site contact (verified)
Aine DeBhalis, DrPrincipal Investigator

Leicester General Hospital

Leicester LE5 4PW, United Kingdom

Recruiting
Site contact (verified)
Osasuyi, Iyasere, DrPrincipal Investigator

St Helier Hospital

Carshalton SM5 1AA, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ayesha Irtiza-Ali, DrPrincipal Investigator

Aintree University Hospital

Liverpool L9 7AL, United Kingdom

Recruiting
Site contact (verified)
Chris Goldsmith, DrPrincipal Investigator

Norfolk and Norwich University Hospital

Norwich NR4 7UY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Matt Todd, DrPrincipal Investigator

Antrim Area Hospital

Antrim BT41 2RL, United Kingdom

Recruiting
Site contact (verified)
Stephanie Bolton, DrPrincipal Investigator

Ulster Hospital

Belfast BT16 1RH, United Kingdom

Recruiting
Site contact (verified)
Alastair Woodman, DrPrincipal Investigator

Altnagelvin Hospital

Londonderry BT47 6SB, United Kingdom

Recruiting
Site contact (verified)
Frank McCarroll, DrPrincipal Investigator

Daisy Hill Hospital

Newry BT35 8DR, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Neal Morgan, DrPrincipal Investigator

Oxford Kidney Unit, Churchill Hospital,

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Tom Connor, DrPrincipal Investigator

Doncaster Royal Infirmary

Doncaster DN2 5LT, United Kingdom

Recruiting
Site contact (verified)
Mohsen El Kossi, DrPrincipal Investigator

Sheffield Kidney Institute

Sheffield S5 7AU, United Kingdom

Recruiting
Site contact (verified)
Ragada El-Damanawi, DrPrincipal Investigator

Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Dominic De Takats, DrPrincipal Investigator

Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
John Sayer, DrPrincipal Investigator

Queen Elizabeth Hospital Birmingham

Birmingham B15 2GW, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Yuki Heath, DrPrincipal Investigator

Bradford Renal Unit, St Luke's Hospital

Bradford BD5 0NA, United Kingdom

Recruiting
Site contact (verified)
Mohd Furqan, DrPrincipal Investigator

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

Epsom and St Helier University Hospitals

Carshalton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Please contact ESTH.Research@nhs.net

ESTH.Research@nhs.net0208 2964699

The Royal London Hospital

London E1 1FR, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Conor Byrne, DrPrincipal Investigator

Royal Free Hospital

London NW3 2QG, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Daniel Gale, DrPrincipal Investigator

King's College Hospital

London SE5 9RS, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Adam Rumjon, DrPrincipal Investigator

St George's University Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Nottingham University Hospital

Nottingham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

East & North Hertfordshire Teaching NHS Trust

Stevenage, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)

mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069

South Tyneside and Sunderland NHS Foundation Trust

Sunderland, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development stsft.research@nhs.net

stsft.research@nhs.net0191 565 6256 ext 42143

York and Scarborough Teacehing Hospitals

York, United Kingdom

Recruiting
Hospital R&D contact (matched)

Lydia Harris

yhs-tr.research.governance@nhs.net01904 726606

How to Get in Touch

Misa Matsuyama, PhD

Sponsor contact

CONTACT

+61 437 759 894 impedepkd@uq.edu.au

Pushparaj Velayudham

Sponsor contact

CONTACT

+61 438 077 278 impedepkd@uq.edu.au
Data sourced from ClinicalTrials.gov · Last verified: 2026-03