Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)
Overview
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 growth of kidney cysts, thereby slowing the rate of kidney function decline, reducing morbidity and mortality and improving the quality of life for ADPKD patients.
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 randomized controlled trial to investigate the effect of metformin on ADPKD disease progression. The study will recruit a total of 1,164 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.
Enrolled participants will be randomized to either (1) intervention group receiving metformin extended release (XR) plus standard of care, or (2) placebo plus standard of care.
You may be able to participate if you:
- Are between the ages 18-70 at the time of screening
- Have a confirmed diagnosis of ADPKD by imaging or genetic (DNA) analysis
- Have an eGFR equal to or greater than 45 mL/min/1.73m2 and <90 mL/min/1.73m2/li>
- Do not have diabetes mellitus
- Are not taking tolvaptan
- Are not currently taking metformin
Other eligibility criteria will apply
Study drug and assessments will be provided at no cost. Reimbursements for reasonable study related expenses, may be provided.
Locations:
Australia, New South Wales
- Renal Research
- Gosford, New South Wales, Australia, 2250
- Contact: Simon Roger, PI sdroger@bigpond.net.au
- Royal Prince Alfred Hospital
- Sydney, New South Wales, Australia, 2050
- Royal North Shore Hospital
- Sydney, New South Wales, Australia, 2065
- Westmead Hospital – Western Sydney Local Health District
- Sydney, New South Wales, Australia, 2145
Australia, Queensland
- Bundaberg Hospital
- Bundaberg, Queensland, Australia, 4670
- Townsville University Hospital
- Douglas, Queensland, Australia, 4814
- Contact: Vikas Srivastava, MD, FRACP +61744335091 vikas.srivastava@health.qld.gov.au
- Royal Brisbane and Women’s Hospital
- Herston, Queensland, Australia, 4006
- Contact: Martin Wolley, PI Martin.Wolley@health.qld.gov.au
- Princess Alexandra Hospital
- Woolloongabba, Queensland, Australia, 4102
- Contact: Andrea Viecelli, PI andrea.viecelli@health.qld.gov.au
- Contact: Rachael Hale, SC 07 – 3240 7466 rachael.hale@health.qld.gov.au
Australia, South Australia
- Royal Adelaide Hospital
- Adelaide, South Australia, Australia, 5000
- Contact: Randall Faull, PI randall.faull@sa.gov.au
- Contact: Bronwyn Hockley, SC 08 – 7074 3077 bronwyn.hockley@sa.gov.au
Australia, Victoria
- Austin Health
- Melbourne, Victoria, Australia, 3084
- Contact: Mardiana Lee, PI Mardiana.Lee@austin.org.au
- Contact: Marieke Veenendaal, SC 03 – 9496 3069 Marieke.Veenendaal@austin.org.au
- Monash Health
- Melbourne, Victoria, Australia, 3168
Australia, Western Australia
- Sir Charles Gairdner Hospital
- Perth, Western Australia, Australia, 6009
Principal Investigator: Andrew Mallett, MBBS, PhD Townsville University Hospital