UK-wide trial testing whether 'less medicine' may be just as effective for some patients with advanced chronic kidney disease

Press release issued: 12 March 2020

A new UK-wide clinical trial is looking to recruit around 500 patients aged over 65-years with low kidney function and other health problems to better understand the pros and cons of different options should their kidneys fail. The study is announced today on World Kidney Day.

Current evidence around treatment options for patients with the advanced stages of kidney disease, which include dialysis, transplantation and conservative care – a form of treatment that aims to maintain a patient’s quality-of-life through symptom management without the intervention of surgery or dialysis, is limited. Some studies have shown that some older people with other medical problems do just as well with conservative care as they would be expected to do with dialysis, but more evidence is needed.

The Prepare for Kidney Care trial is the first ever randomised controlled trial to compare the benefits of preparing patients for dialysis versus conservative care. Importantly, the study will provide high-quality data on quality-of-life and survival rates – something that the patients involved in designing the trial considered essential. The results will be used to inform future patients, relatives and clinical teams on the outcomes that can be expected with each option so that a patient’s choice can be matched to their individual preferences and priorities.

This NIHR-funded study aims to recruit people with advanced chronic kidney disease aged 80+ and those aged 65+ with multiple health problems. If they agree to take part, they will be allocated to:

• Either, prepare for responsive management (a form of conservative care developed for this trial). This will involve home visits with a nurse to assess their care needs and priorities for care. The nurse will call the patient at home regularly to monitor symptoms and check that sufficient help is available. Hospital visits will be less frequent than in people preparing for dialysis.

• Or, prepare for dialysis. This will involve regular hospital clinic visits as currently happens outside the study. Surgery to prepare for dialysis will take place when required and dialysis will be started if or when the doctor, nurse and patient agree it is needed. There will be regular visits to hospital for treatment or check-ups.

Patients can only take part in the trial if they have the mental capacity to do so, in other words to make an informed decision to allow this treatment decision to be made for them through randomisation. As with any trial, they can decide to come off their allocated treatment at any time if they feel that it is no longer right for them. If they do so, they return to routine NHS care. Importantly, if a patient in the trial loses the mental capacity to make informed decisions about their care, they are withdrawn from the trial and returned to routine NHS care.

Dr Fergus Caskey, the trial Chief Investigator, consultant senior lecturer at the University of Bristol and honorary consultant nephrologist at North Bristol NHS Trust, said: “The study aims to not only influence NHS policy on care for this group of patients, but to provide relevant information that can be tailored to individual people making decisions about dialysis and conservative care in the future.

“A kidney transplant is considered the best treatment for many people with kidney failure but it is not medically suitable for everyone. While dialysis and conservative care are excellent treatments used by many thousands of patients in the UK, some kidney teams tend to prepare patients with multiple health problems for conservative care, while others tend to prepare them for dialysis. What patients choose at the moment seems to depend on where they live and which doctor they see. When we see variation in treatment patterns like this it is a sure sign that better evidence is needed to guide decision making.

“The results of this trial will bridge this knowledge gap through more-informed NHS guidance for clinicians and more reliable information on what to expect for patients faced with making the decision.”

More information about the Prepare for Kidney Care study is available on the website. If you are interested in taking part in this trial and would like further information, please contact Helen Winton, Prepare for Kidney Care Trial Manager, email, Helen.winton@bristol.ac.uk, tel, 0117 331 4586.

Further information

About Advanced Chronic Kidney Disease

When kidney function drops to 15 per cent of normal, symptoms such as tiredness, loss of appetite and sickness usually develop. At this stage, dialysis or kidney transplantation is considered. This more often affects older people – half of all patients starting dialysis now are aged 65+ with 3,500 patients affected per year in the UK.

Dialysis involves visiting the hospital for four hours of treatment, three times a week, or flushing fluid in and out of your system through your abdomen four times a day every day at home.

Some people receiving dialysis accommodate to its requirements well and achieve good quality of life, but others report very poor quality of life on dialysis. For these reasons, some patients choose to have as much symptom management and control as possible without dialysis - known as “conservative care”. There is evidence that some older people with many medical problems (co-morbidities) do just as well with conservative care as dialysis, but more evidence is needed to help patients and their families make the best decision. The Prepare for Kidney Care study aims to provide far better evidence to help patients and their families reach the best decision for them and influence NHS policy on care for this group of patients.