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Diabetes drug metformin tested as new weapon against kidney disease

NCT ID NCT04939935

Disease control Sponsor: The University of Queensland Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether metformin, a drug used for diabetes, can slow the loss of kidney function in people with early-stage autosomal dominant polycystic kidney disease (ADPKD). About 1,174 adults aged 18-70 with mild to moderate kidney decline will take metformin or a placebo for two years. The goal is to see if metformin can help preserve kidney function and improve quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,174 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autosomal dominant polycystic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autosomal dominant polycystic kidney disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aintree University Hospital

    RECRUITING

    Liverpool, Merseyside, L9 7AL, United Kingdom

  • Altnagelvin Hospital

    RECRUITING

    Londonderry, Northern Ireland, BT47 6SB, United Kingdom

  • Antrim Area Hospital

    RECRUITING

    Antrim, Northern Ireland, BT41 2RL, United Kingdom

  • Austin Health

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3084, Australia

  • Bradford Renal Unit, St Luke's Hospital

    RECRUITING

    Bradford, West Yorkshire, BD5 0NA, United Kingdom

  • Bundaberg Hospital

    ACTIVE_NOT_RECRUITING

    Bundaberg, Queensland, 4670, Australia

  • Cardiff and Vale University Health Board

    RECRUITING

    Cardiff, United Kingdom

  • Daisy Hill Hospital

    NOT_YET_RECRUITING

    Newry, Northern Ireland, BT35 8DR, United Kingdom

  • Doncaster Royal Infirmary

    RECRUITING

    Doncaster, South Yorkshire, DN2 5LT, United Kingdom

  • East & North Hertfordshire Teaching NHS Trust

    RECRUITING

    Stevenage, United Kingdom

  • Epsom and St Helier University Hospitals

    RECRUITING

    Carshalton, United Kingdom

  • Freeman Hospital

    NOT_YET_RECRUITING

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • King's College Hospital

    NOT_YET_RECRUITING

    London, SE5 9RS, United Kingdom

  • Leicester General Hospital

    RECRUITING

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Monash Medical Centre

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3168, Australia

  • Norfolk and Norwich University Hospital

    NOT_YET_RECRUITING

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Nottingham Renal Unit, Nottingham City Hospital

    NOT_YET_RECRUITING

    Nottingham, East Midlands, NG5 1PB, United Kingdom

  • Nottingham University Hospital

    RECRUITING

    Nottingham, United Kingdom

  • Oxford Kidney Unit, Churchill Hospital,

    RECRUITING

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Princess Alexandra Hospital

    ACTIVE_NOT_RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth Hospital Birmingham

    NOT_YET_RECRUITING

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • Raigmore Hospital

    NOT_YET_RECRUITING

    Inverness, Inverness Shire, IV2 3UJ, United Kingdom

  • Renal Research

    ACTIVE_NOT_RECRUITING

    Gosford, New South Wales, 2250, Australia

  • Royal Adelaide Hospital

    ACTIVE_NOT_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Women's Hospital

    ACTIVE_NOT_RECRUITING

    Herston, Queensland, 4006, Australia

  • Royal Devon & Exeter Hospital

    RECRUITING

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Free Hospital

    NOT_YET_RECRUITING

    London, NW3 2QG, United Kingdom

  • Royal Melbourne Hospital

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3052, Australia

  • Royal North Shore Hospital

    ACTIVE_NOT_RECRUITING

    Sydney, New South Wales, 2065, Australia

  • Royal Preston Hospital

    NOT_YET_RECRUITING

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Royal Prince Alfred Hospital

    ACTIVE_NOT_RECRUITING

    Sydney, New South Wales, 2050, Australia

  • Royal Stoke University Hospital

    NOT_YET_RECRUITING

    Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

  • Salford Royal Hospital

    RECRUITING

    Salford, Lancashire, M6 8HD, United Kingdom

  • Sheffield Kidney Institute

    RECRUITING

    Sheffield, South Yorkshire, S5 7AU, United Kingdom

  • Sir Charles Gairdner Hospital

    ACTIVE_NOT_RECRUITING

    Perth, Western Australia, 6009, Australia

  • South Tyneside and Sunderland NHS Foundation Trust

    RECRUITING

    Sunderland, United Kingdom

  • St George's University Hospital

    RECRUITING

    London, United Kingdom

  • St Helier Hospital

    NOT_YET_RECRUITING

    Carshalton, London, SM5 1AA, United Kingdom

  • Ta Pae Hauora o Ruhahine o Terarua Mid Central

    RECRUITING

    Palmerston North, New Zealand

  • Te Whatu Ora - Hauora a Toi Bay of Plenty

    RECRUITING

    Tauranga, Bay of Plenty, 3112, New Zealand

  • Te Whatu Ora - Southern

    RECRUITING

    Dunedin, Otago, 9016, New Zealand

  • Te Whatu Ora - Taranaki

    RECRUITING

    New Plymouth, Taranaki Region, 4310, New Zealand

  • Te Whatu Ora - Te Tai Tokerau

    RECRUITING

    Whangārei, Northland, 0110, New Zealand

  • The Royal London Hospital

    NOT_YET_RECRUITING

    London, E1 1FR, United Kingdom

  • Townsville University Hospital

    ACTIVE_NOT_RECRUITING

    Douglas, Queensland, 4814, Australia

  • Ulster Hospital

    RECRUITING

    Belfast, Northern Ireland, BT16 1RH, United Kingdom

  • University Hospitals Plymouth NHS Trust

    RECRUITING

    Plymouth, United Kingdom

  • Westmead Hospital - Western Sydney Local Health District

    ACTIVE_NOT_RECRUITING

    Sydney, New South Wales, 2145, Australia

  • York and Scarborough Teacehing Hospitals

    RECRUITING

    York, United Kingdom

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