IMPEDE-PKD Trial

Researchers think a drug called metformin, used to treat Type 2 Diabetes, may slow down kidney damage for people with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The IMPEDE-PKD trial aims to find out whether taking a metformin tablet daily compared to a placebo “dummy” tablet slows the rate of cyst growth and kidney function decline in people with ADPKD.

The UK team will also study chronic pain in ADPKD—how people manage it now, and whether metformin can help reduce it. This is a global study which aims to recruit 300 people from the UK.

Who can take part?

The clinical trial has strict inclusion criteria about who can and can’t take part.

Eligibility:

• Confirmed ADPKD by genetic testing and/or imaging
• eGFR ≥ 38 and < 90
• Risk of progression due to size or aggressive genetic mutation or,
• Active disease progression i.e. kidneys growing very fast or function declining rapidly

NB. Tolvaptan patients will be eligible to take part in the study providing they are on a stable dose, have no complications and are tolerating it well.

Exclusions:

• Patients with diabetes
• Patients with any condition that can affect the kidneys or the trial data including organ transplant
• history of dialysis

 What is involved?

Participation takes place over a 12 week run-in phase followed by a 2 year treatment phase. You will have:

The run-in phase identifies the maximum dose of metformin suitable for each individual so the dose you take may change during this time. Participants must safely and successfully complete the run-in phase before being able to complete the treatment phase. Only those participants who are eligible and willing will proceed to the treatment phase.

The study reviews will be by phone call or require you to attend the hospital (where possible these visits will be scheduled to coincide with your standard clinic appointments). The reviews are to: check it is safe for you and that you are willing to take part, collect clinical and questionnaire data to help answer the study’s questions, and give you your trial medication to take at home.

Study assessments include:

• Medical history
• Physical examination
• Blood tests
• Urine tests
• Questionnaires

Learn more about the IMPEDE-PKD study and watch our PKD Live Q&A with Dr. Ragada El-Damanawi, Consultant Nephrologist at the Sheffield Kidney Institute and UK Chief Investigator for IMPEDE-PKD.

PLAYWatch on YouTube

Where can I take part?

The trial aims to have thirty participating centres across the UK. Hospitals are in the process of becoming trial centres and 32 centres are now open and actively recruiting:

How do I find out more?

If you’d like to learn more about the trial or check your eligibility with the trial team at recruiting centres, please contact the PKD Charity PPIE Officer at [email protected]. More sites will open as the trial continues.

Further details about the trial can also be viewed here or by scanning the QR code with your mobile phone.