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Clinical Trials in Australia / NCT04939935
Recruiting Phase 3

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

NCT04939935 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2022-11-29
Last updated
2026-03-31

Condition(s) studied

Autosomal Dominant Polycystic Kidney Disease

Investigational drug(s) / intervention(s)

Metformin XR →Control

Metformin XR: Extended release metformin.

Control: Placebo is inactive tablets that is identical to the intervention Metformin tablets.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Renal Research Gosford New South Wales Active Not Recruiting
Royal Prince Alfred Hospital Sydney New South Wales Active Not Recruiting
Royal North Shore Hospital Sydney New South Wales Active Not Recruiting
Westmead Hospital - Western Sydney Local Health District Sydney New South Wales Active Not Recruiting
Bundaberg Hospital Bundaberg Queensland Active Not Recruiting
Townsville University Hospital Douglas Queensland Active Not Recruiting
Royal Brisbane and Women's Hospital Herston Queensland Active Not Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Active Not Recruiting
Royal Adelaide Hospital Adelaide South Australia Active Not Recruiting
Royal Melbourne Hospital Melbourne Victoria Active Not Recruiting
Austin Health Melbourne Victoria Active Not Recruiting
Monash Medical Centre Melbourne Victoria Active Not Recruiting
Sir Charles Gairdner Hospital Perth Western Australia Active Not Recruiting
Te Whatu Ora - Hauora a Toi Bay of Plenty Tauranga Bay of Plenty Recruiting
Te Whatu Ora - Te Tai Tokerau Whangārei Northland Recruiting
Te Whatu Ora - Southern Dunedin Otago Recruiting
Te Whatu Ora - Taranaki New Plymouth Taranaki Region Recruiting
Ta Pae Hauora o Ruhahine o Terarua Mid Central Palmerston North New Zealand Recruiting
Royal Devon & Exeter Hospital Exeter Devon Recruiting
Nottingham Renal Unit, Nottingham City Hospital Nottingham East Midlands Not Yet Recruiting
Raigmore Hospital Inverness Inverness Shire Not Yet Recruiting
Royal Preston Hospital Preston Lancashire Not Yet Recruiting
Salford Royal Hospital Salford Lancashire Recruiting
Leicester General Hospital Leicester Leicestershire Recruiting
St Helier Hospital Carshalton London Not Yet Recruiting
Aintree University Hospital Liverpool Merseyside Recruiting
Norfolk and Norwich University Hospital Norwich Norfolk Not Yet Recruiting
Antrim Area Hospital Antrim Northern Ireland Recruiting
Ulster Hospital Belfast Northern Ireland Recruiting
Altnagelvin Hospital Londonderry Northern Ireland Recruiting
Daisy Hill Hospital Newry Northern Ireland Not Yet Recruiting
Oxford Kidney Unit, Churchill Hospital, Oxford Oxfordshire Recruiting
Doncaster Royal Infirmary Doncaster South Yorkshire Recruiting
Sheffield Kidney Institute Sheffield South Yorkshire Recruiting
Royal Stoke University Hospital Stoke-on-Trent Staffordshire Not Yet Recruiting
Freeman Hospital Newcastle upon Tyne Tyne and Wear Not Yet Recruiting
Queen Elizabeth Hospital Birmingham Birmingham West Midlands Not Yet Recruiting
Bradford Renal Unit, St Luke's Hospital Bradford West Yorkshire Recruiting
Cardiff and Vale University Health Board Cardiff United Kingdom Recruiting
Epsom and St Helier University Hospitals Carshalton United Kingdom Recruiting

+ 9 more sites — see the full list on the official registry below.

More The University of Queensland trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04939935 on ClinicalTrials.gov ↗ ← All trials in Australia