Implementation of Metformin theraPy to Ease DEcline of kidney function in PKD
Principal Investigators: Andrew Mallett
Clinical Project Manager: Liza Vergara (AKTN), Donna Reidlinger (AKTN)
Clinical Research Associate:
Trial Number: AKTN 16.01
Population: Adults with CKD stages 2-3a and rapidly progressing ADPKD
Intervention: Metformin (1000mg/2tablets BD) vs placebo (2tablets BD)
Follow-up: 3 years
Primary outcome: Change in eGFR (CKD-EPI)
Status: Recruitment to commence 1st Q 2019
Target Recruitment: Australia
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.
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.