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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Miss
Megan
Jones
megan.l.jones@uea.ac.uk
Dr
Ragada
El-Damanawi
ragada.eldamanawi1@nhs.net
Autosomal dominant polycystic kidney disease (ADPKD)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Autosomal dominant polycystic kidney disease (ADPKD) is a leading cause of kidney failure. This inherited condition causes the development of fluid-filled sacs called cysts within the kidneys. Cysts grow over time, damaging and replacing healthy kidney tissue, stopping them from 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. 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Diabetes mellitus (as per American Diabetes Association definition) or other systemic conditions that may cause Chronic Kidney Disease (CKD) independent of Polycystic Kidney Disease (PKD) (excluding hypertension)2. Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg after a period of rest)3. Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV4. Non-polycystic liver disease, including but not limited to: 4.1. Liver enzymes (ALT, AST or Total Bilirubin) >2 times the upper limit of normal 4.2. In the case of Gilbert’s Syndrome; liver enzymes (ALT, AST) >2 times the upper limit of normal and/or total bilirubin >3 times the upper limit of normal 4.3. Child-Pugh classification score ≥5 5. Any contraindication to metformin and/or placebo excipients6. Currently taking metformin7. Pregnancy or breastfeeding, or planning to get pregnant in the next 3 years8. Women of childbearing potential not using a highly effective form of contraception9. Comorbidities with contraindication for metformin use or potential to contaminate trial outcomes (specifically active cancer, and/or history of other solid organ transplantations (kidney, heart, liver, lung, bowel), and/or presence of stoma10. Active chronic obstructive pulmonary disease (COPD), active inflammatory bowel disease (IBD), or other active disease resulting in current or expected requirement for systemic steroid therapy during the trial follow-up period11. History of dialysis12. Participation in the active phase of another CTIMP, or within 4 weeks or 5 half-lives of last study drug administration (whichever is longer)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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You can print or share the study information with your GP/healthcare provider or contact the research team directly.
