Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT04939935

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

Led by The University of Queensland · Updated on 2026-03-31

1174

Participants Needed

49

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to participate and provide informed consent
  • Aged 18-70 years
  • Diagnosis of ADPKD based on radiological or genetic criteria as per Kidney Health Australia guidelines
  • eGFR equal to or greater than 38 mL/min/1.73m2 and less than 90 mL/min/1.73m2
  • Have one or more risk factors of progression such as bilateral kidney length ≥16.5 cm, total kidney volume ≥750 mL, height-adjusted total kidney volume ≥600 mL/m2, Mayo class IC/D/E, or Pro-PKD score ≥6
  • Or evidence of active progression shown by decline in eGFR ≥5 mL/min/1.73m2 in one year, or decline in eGFR ≥3 mL/min/1.73m2 per year over five or more years, or increase in kidney volume ≥5% per year on at least two measurements in the past year with specific conditions for those on tolvaptan therapy
Not Eligible

You will not qualify if you...

  • Diagnosis of diabetes mellitus or other systemic conditions causing chronic kidney disease independent of PKD (excluding hypertension)
  • Uncontrolled hypertension with systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg after rest
  • Clinically significant heart failure classified as New York Heart Association Class III or IV
  • Non-polycystic liver disease with liver enzymes more than twice the normal limit or Child-Pugh score ≥5
  • Contraindications to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency
  • Currently taking metformin
  • Pregnant, breastfeeding, or planning pregnancy within three years
  • Comorbidities that may affect trial outcomes including active cancer, history of solid organ transplants, active COPD, active inflammatory bowel disease, or presence of a stoma
  • History of dialysis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 49 locations

1

Renal Research

Gosford, New South Wales, Australia, 2250

Active, Not Recruiting

2

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia, 2050

Active, Not Recruiting

3

Royal North Shore Hospital

Sydney, New South Wales, Australia, 2065

Active, Not Recruiting

4

Westmead Hospital - Western Sydney Local Health District

Sydney, New South Wales, Australia, 2145

Active, Not Recruiting

5

Bundaberg Hospital

Bundaberg, Queensland, Australia, 4670

Active, Not Recruiting

6

Townsville University Hospital

Douglas, Queensland, Australia, 4814

Active, Not Recruiting

7

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia, 4006

Active, Not Recruiting

8

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Active, Not Recruiting

9

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Active, Not Recruiting

10

Royal Melbourne Hospital

Melbourne, Victoria, Australia, 3052

Active, Not Recruiting

11

Austin Health

Melbourne, Victoria, Australia, 3084

Active, Not Recruiting

12

Monash Medical Centre

Melbourne, Victoria, Australia, 3168

Active, Not Recruiting

13

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia, 6009

Active, Not Recruiting

14

Te Whatu Ora - Hauora a Toi Bay of Plenty

Tauranga, Bay of Plenty, New Zealand, 3112

Actively Recruiting

15

Te Whatu Ora - Te Tai Tokerau

Whangārei, Northland, New Zealand, 0110

Actively Recruiting

16

Te Whatu Ora - Southern

Dunedin, Otago, New Zealand, 9016

Actively Recruiting

17

Te Whatu Ora - Taranaki

New Plymouth, Taranaki Region, New Zealand, 4310

Actively Recruiting

18

Ta Pae Hauora o Ruhahine o Terarua Mid Central

Palmerston North, New Zealand

Actively Recruiting

19

Royal Devon & Exeter Hospital

Exeter, Devon, United Kingdom, EX2 5DW

Actively Recruiting

20

Nottingham Renal Unit, Nottingham City Hospital

Nottingham, East Midlands, United Kingdom, NG5 1PB

Not Yet Recruiting

21

Raigmore Hospital

Inverness, Inverness Shire, United Kingdom, IV2 3UJ

Not Yet Recruiting

22

Royal Preston Hospital

Preston, Lancashire, United Kingdom, PR2 9HT

Not Yet Recruiting

23

Salford Royal Hospital

Salford, Lancashire, United Kingdom, M6 8HD

Actively Recruiting

24

Leicester General Hospital

Leicester, Leicestershire, United Kingdom, LE5 4PW

Actively Recruiting

25

St Helier Hospital

Carshalton, London, United Kingdom, SM5 1AA

Not Yet Recruiting

26

Aintree University Hospital

Liverpool, Merseyside, United Kingdom, L9 7AL

Actively Recruiting

27

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom, NR4 7UY

Not Yet Recruiting

28

Antrim Area Hospital

Antrim, Northern Ireland, United Kingdom, BT41 2RL

Actively Recruiting

29

Ulster Hospital

Belfast, Northern Ireland, United Kingdom, BT16 1RH

Actively Recruiting

30

Altnagelvin Hospital

Londonderry, Northern Ireland, United Kingdom, BT47 6SB

Actively Recruiting

31

Daisy Hill Hospital

Newry, Northern Ireland, United Kingdom, BT35 8DR

Not Yet Recruiting

32

Oxford Kidney Unit, Churchill Hospital,

Oxford, Oxfordshire, United Kingdom, OX3 7LE

Actively Recruiting

33

Doncaster Royal Infirmary

Doncaster, South Yorkshire, United Kingdom, DN2 5LT

Actively Recruiting

34

Sheffield Kidney Institute

Sheffield, South Yorkshire, United Kingdom, S5 7AU

Actively Recruiting

35

Royal Stoke University Hospital

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

Not Yet Recruiting

36

Freeman Hospital

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

Not Yet Recruiting

37

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, United Kingdom, B15 2GW

Not Yet Recruiting

38

Bradford Renal Unit, St Luke's Hospital

Bradford, West Yorkshire, United Kingdom, BD5 0NA

Actively Recruiting

39

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Actively Recruiting

40

Epsom and St Helier University Hospitals

Carshalton, United Kingdom

Actively Recruiting

41

The Royal London Hospital

London, United Kingdom, E1 1FR

Not Yet Recruiting

42

Royal Free Hospital

London, United Kingdom, NW3 2QG

Not Yet Recruiting

43

King's College Hospital

London, United Kingdom, SE5 9RS

Not Yet Recruiting

44

St George's University Hospital

London, United Kingdom

Actively Recruiting

45

Nottingham University Hospital

Nottingham, United Kingdom

Actively Recruiting

46

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Actively Recruiting

47

East & North Hertfordshire Teaching NHS Trust

Stevenage, United Kingdom

Actively Recruiting

48

South Tyneside and Sunderland NHS Foundation Trust

Sunderland, United Kingdom

Actively Recruiting

49

York and Scarborough Teacehing Hospitals

York, United Kingdom

Actively Recruiting

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Research Team

M

Misa Matsuyama, PhD

CONTACT

P

Pushparaj Velayudham

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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