Protein levels in urine are reliable measure of effectiveness in kidney disease research says study

An international consortium of doctors and scientists, including members from Leicester’s Hospitals and the University of Leicester, has found that protein levels in urine are a reliable way to measure the effectiveness of a medicine, device or treatment on the progress of kidney disease during clinical research.

The paper, published in The Lancet, could mean that substantially more trials into kidney disease could be conducted – giving hope to the three million people in the UK who have it and for which there is currently no cure. It has come ahead of World Kidney Day, an annual global awareness and education campaign, which takes place today, Thursday 14 March.

Professor Nigel Brunskill, consultant nephrologist at Leicester’s Hospitals, said: “It is difficult to evaluate new treatments in kidney disease at present because it is hard to measure changes in kidney function (known as trial endpoints).

“As a result, there are fewer clinical trials into the causes and treatment of kidney disorders than in other specialities, such as cardiovascular and respiratory disease. Fewer trials limit the availability of more effective approaches to treating – and eventually curing – kidney disease.

“In this paper we have determined that measuring protein levels in urine (specifically albuminuria) may be an easy and reliable way of measuring the effects of a range of kidney treatments – from medicines, to exercise, to the insertion of a device.”

There are many causes of kidney disease – including diabetes and high blood pressure. Some forms of kidney disease can also be inherited or caused by an autoimmune disorder (when the body attacks itself).

The study was funded locally by National Institute for Health Research (NIHR) Collaboration in Leadership for Applied Research in Health and Care (CLAHRC) East Midlands and involved a meta-analysis of data from previous studies with large groups of patients.

Professor Kamlesh Khunti, director of the NIHR CLAHRC East Midlands, said: “I am sure these findings will be really welcome news for researchers in nephrology. If they can reliably measure the effects of new medicines, exercise programmes or other interventions to manage and treat the symptoms of chronic kidney disease more easily, they could run more clinical trials than at present.

“A higher volume of clinical trials testing a greater number of treatments for efficacy would – ultimately - provide hope for better outcomes for patients with a range of kidney diseases in the future.”

An editorial in the same paper welcomed the findings. It went on to state that specific clinical trials to define the baseline protein levels in urine should now be a focus for further research to help determine what is a ‘clinically meaningful treatment’.