STH21643 IMPEDE-PKD Investigational Medicinal Product (IMP) Tender

Tender description

IMPEDE-PKD is a global clinical trial, with a recruitment target of over 1000 participants (with 300 being recruited in the UK). It is a pragmatic, multi-centre, double blind parallel group randomised controlled trial of metformin versus placebo in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The primary objective is to evaluate the long-term efficacy of metformin therapy in slowing the rate of kidney function decline in metformin versus placebo treated ADPKD subjects. In the UK, the trial will also be using the UK validated and standardised ADPKD-Pain Assessment Tool (APAT) to measure and evaluate the characteristics of pain. ADPKD is a leading cause of kidney failure and accounts for 11% of prevalent UK kidney replacement therapy (KRT) patients. Rapidly expanding cysts damage the kidney parenchyma causing kidney failure, debilitating chronic pain and reduced quality of life. Currently tolvaptan is the only licensed treatment. However, its use is limited to those with rapid disease progression (often a late sign) and its side effect profile leads to high discontinuation rates. It is also associated with a high cost. Metformin has been used in diabetics for decades and is a low cost, safe and wellestablished therapy that may also slow kidney function decline in ADPKD. It targets two key cystogenic signalling pathways providing a potentially valuable therapy that can be repurposed for the treatment of ADPKD.