Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD): A Randomised Placebo-Controlled Trial

Who is this study for? Patients with polycystic kidney disease
What treatments are being studied? Metformin
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

‣ To be eligible to participate in this trial, patients must satisfy all of the following inclusion criteria:

⁃ Willing to participate and provide informed consent

⁃ Aged 18-70 years

⁃ 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

⁃ 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.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Bundaberg Hospital
ACTIVE_NOT_RECRUITING
Bundaberg
Townsville University Hospital
ACTIVE_NOT_RECRUITING
Douglas
Renal Research
ACTIVE_NOT_RECRUITING
Gosford
Royal Brisbane and Women's Hospital
ACTIVE_NOT_RECRUITING
Herston
Austin Health
ACTIVE_NOT_RECRUITING
Melbourne
Monash Medical Centre
ACTIVE_NOT_RECRUITING
Melbourne
Royal Melbourne Hospital
ACTIVE_NOT_RECRUITING
Melbourne
Sir Charles Gairdner Hospital
ACTIVE_NOT_RECRUITING
Perth
Royal North Shore Hospital
ACTIVE_NOT_RECRUITING
Sydney
Royal Prince Alfred Hospital
ACTIVE_NOT_RECRUITING
Sydney
Westmead Hospital - Western Sydney Local Health District
ACTIVE_NOT_RECRUITING
Sydney
Princess Alexandra Hospital
ACTIVE_NOT_RECRUITING
Woolloongabba
New Zealand
Te Whatu Ora - Southern
RECRUITING
Dunedin
Te Whatu Ora - Taranaki
RECRUITING
New Plymouth
Te Whatu Ora - Hauora a Toi Bay of Plenty
RECRUITING
Tauranga
Te Whatu Ora - Te Tai Tokerau
RECRUITING
Whangārei
United Kingdom
Antrim Area Hospital
NOT_YET_RECRUITING
Antrim
Ulster Hospital
NOT_YET_RECRUITING
Belfast
Queen Elizabeth Hospital Birmingham
NOT_YET_RECRUITING
Birmingham
Bradford Renal Unit, St Luke's Hospital
NOT_YET_RECRUITING
Bradford
St Helier Hospital
NOT_YET_RECRUITING
Carshalton
Doncaster Royal Infirmary
NOT_YET_RECRUITING
Doncaster
Royal Devon & Exeter Hospital
NOT_YET_RECRUITING
Exeter
Raigmore Hospital
NOT_YET_RECRUITING
Inverness
Leicester General Hospital
NOT_YET_RECRUITING
Leicester
Aintree University Hospital
NOT_YET_RECRUITING
Liverpool
King's College Hospital
NOT_YET_RECRUITING
London
Royal Free Hospital
NOT_YET_RECRUITING
London
The Royal London Hospital
NOT_YET_RECRUITING
London
Altnagelvin Hospital
NOT_YET_RECRUITING
Londonderry
Freeman Hospital
NOT_YET_RECRUITING
Newcastle Upon Tyne
Daisy Hill Hospital
NOT_YET_RECRUITING
Newry
Norfolk and Norwich University Hospital
NOT_YET_RECRUITING
Norwich
Nottingham Renal Unit, Nottingham City Hospital
NOT_YET_RECRUITING
Nottingham
Oxford Kidney Unit, Churchill Hospital,
NOT_YET_RECRUITING
Oxford
Royal Preston Hospital
NOT_YET_RECRUITING
Preston
Salford Royal Hospital
NOT_YET_RECRUITING
Salford
Sheffield Kidney Institute
NOT_YET_RECRUITING
Sheffield
Royal Stoke University Hospital
NOT_YET_RECRUITING
Stoke-on-trent
Contact Information
Primary
Misa Matsuyama, PhD
impedepkd@uq.edu.au
+61 437 759 894
Backup
Pushparaj Velayudham
impedepkd@uq.edu.au
+61 438 077 278
Time Frame
Start Date: 2022-11-29
Estimated Completion Date: 2027-05
Participants
Target number of participants: 1174
Treatments
Experimental: Intervention
Participants randomised to the intervention group receive Metformin XR plus standard of care for 104 weeks.~Dosage will depend on individual participant's level of tolerance to Metformin XR as well as their estimated glomerular filtration rate (eGFR). The dosage will be between 500-2000mg/day.
Placebo_comparator: Control
Participants randomised to the control group receive placebo plus standard of care for 104 weeks.
Sponsors
Leads: The University of Queensland

This content was sourced from clinicaltrials.gov