Extrait

Background and study aims Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work properly. In a healthy person, the kidneys are vital for filtering out the waste products and excess water in the blood, and converting them into urine. In patients suffering from CKD, the kidneys are unable to do this, and so the body is unable to get rid of the waste products building up in the blood. Haemodialysis is one of the most common treatments for CKD patients, and involves diverting the blood into an external machine so that it can be “cleaned”, before being returned to the body. Haemodialysis requires direct access to the circulatory system (blood stream) and the best option for this is a by creating an arteriovenous fistula (AVF), which is made by surgically joining an artery and a vein in the arm. AVFs have a limited lifespan, and over time become narrowed (stenosed) or blocked (thrombosed). This can lead to a patient being admitted to hospital to have emergency lines fitted in their neck, which can cause infection. The fistula can be used for haemodialysis again if it is “re-opened”. This is done by inflating a small balloon inside the fistula to flatten any blockages against the artery wall (fistuloplasty). In many cases however, the narrowing (stenosis) can return, re-blocking the fistula. Studies have shown that in the legs and heart, using a balloon coated with certain drugs, such as paclitaxel, can prevent cells from multiplying and re-blocking the artery. The aim of this study is to find out whether using paclitaxel coating balloons in a fistuloplasty procedure can help to prevent later AVF stenosis. Who can participate? Adults who have a narrowed AVF, which has been used for haemodialysis at least 12 times. What does the study involve? Participants are randomly allocated to one of two groups. Both groups receive the standard fistuloplasty procedure, in which a plain balloon is inflated until the fistula becomes wide enough to become usable. Those in the first group then receive a second fistuloplasty with a balloon coated in a drug called paclitaxel, which is inserted and inflated until it touches the wall of the blood vessel and transfers the paclitaxel onto the blood vessel wall. Those in the second group receive a second fistuloplasty with a balloon which is not drug coated. Participants attend regular follow-up appointments so that the openness (patency) of the fistula can be monitored. What are the possible benefits and risks of participating? Participants who receive the drug coated balloon treatment may have the chance of a better outcome for their fistula. Risks of participating are minimal, however the fistuloplasty procedure may be uncomfortable and cause pain. Where is the study run from? Guy's Hospital, London (lead centre) and five other NHS hospitals in England (UK) When is the study starting and how long is it expected to run for? November 2015 to November 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Mrs Vikki Semik

Critère d'inclusion

• Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders

Liens

• isrctn
• ictrp