Implementation of Metformin theraPy to Ease DEcline of kidney function in PKD (IMPEDE-PKD)
Principal Investigators: Andrew Mallett
Clinical Project Manager: Alyssa Welch
Clinical Research Associate: Misa Matsuyama
Trial Number: AKTN 16.01
Population: Adults with CKD stages 2-3a and rapidly progressing ADPKD
Intervention: Metformin (plus standard of care) vs placebo (plus standard of care)
Follow-up: 2 years
Primary outcome: Change in eGFR (CKD-EPI) at 104 weeks (24 months) from randomisation
Status: Recruitment to commence early 2021
Target Recruitment: 1,164 participants from Australia, Europe, USA and Asia
Autosomal dominant polycystic kidney disease (ADPKD) is the 4th most common reason for commencement of dialysis in Australia. There is an urgent need for treatments to slow the loss of kidney function and prevent complications in affected patients and families. Repurposing of existing medications is one proposed method to potentially expedite meeting this need in clinical practice.
IMPEDE-PKD is a prospective, multicentre double-blind, randomised controlled trial of metformin versus placebo in adult ADPKD patients to determine the effect of metformin therapy on renal function decline and cyst growth. The aim and objective of this study is to undertake a randomised clinical trial of metformin amongst patients with ADPKD to investigate its potential to slow kidney function decline. Pre-clinical studies suggest that there are ADPKD disease pathways that can be advantageously modified by administration of metformin. The common use of this medication, including in non-diabetic conditions such as polycystic ovarian syndrome, its relative inexpensive nature as well as its defined side effect and dosing profiles in kidney disease lend it to the conduct of a clinical trial to address this aim.
This clinical trial will seek to undertake such a clinical trial within the context of the pre-eminent national kidney trials organisation. If successful, this would dramatically change the prognosis and clinical care for many Australians affected by ADPKD as well as positively impact upon health service utilisation such as dialysis requirement at a community level.
The study received seed funding from the BEAT-CKD NHMRC Program Grant, PKD Foundation Australia, and a donation from Otsuka Australia. The trial is now fully funded by an MRFF Clinical Trials and Cohorts Studies Targeted Call for Research grant.