IMPEDE-PKD
Research type
Research Study
Full title
Implementation of Metformin theraPy to Ease DEcline of kidney function in Polycystic Kidney Disease (IMPEDE-PKD): Randomised Placebo-Controlled Trial
IRAS ID
1010940
Contact name
Ragada El-Damanawi
Contact email
Sponsor organisation
University of Queensland
ISRCTN Number
ISRCTN12436830
Research summary
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a leading cause of kidney failure. This inherited condition causes development of fluid filled sacs called cysts within the kidneys. Cysts grow over time damaging and replacing healthy kidney tissue, stopping them being able to filter the blood effectively. More than 70% of those affected require kidney replacement therapy by the age of 58 years. Currently there is only one treatment available which isn't suitable for everyone and can cause troublesome side effects.
Metformin is a low-cost, widely available medication, safely used to treat diabetes for decades. Recent research has shown metformin blocks two key signals that drive kidney cyst growth, and that it is safe and well tolerated in people with ADPKD. The main side effects are diarrhoea and bloating. These occur in 30% and usually settle within a few weeks and may be alleviated by taking metformin with food.
The study will recruit 1174 ADPKD patients worldwide including 300 participants from UK renal centres. This application concerns the UK contribution to the trial.
60% of ADPKD patients experience chronic pain significantly impacting their lives. The UK trial includes a questionnaire to find out more about the pain and if metformin helps by slowing cyst growth.
During an initial 12 week run-in phase all participants will take metformin daily for 10 weeks to find the optimum acceptable dose for them. All participants will washout for the final two weeks of the run-in. Those that can successfully take metformin at the end of run-in phase will be randomly divided into two groups. Each group will be assigned to either metformin or placebo 'dummy' tablets. The assigned tablet(s) will be taken every day for the next 2 years. Participants will complete questionnaires, provide blood and urine samples, undergo non-invasive physical examinations and blood pressure measurements to ensure their safety and help answer the study's research questions.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0077
Date of REC Opinion
5 Jun 2025
REC opinion
Further Information Favourable Opinion