Oxfordshire study participants welcome NHS approval for kidney drug

Oxfordshire residents who took part in a study into a drug for chronic kidney disease (CKD) said they are “thrilled” it has been approved for use in the NHS.

Michael Pickard and John Crane welcomed approval for empagliflozin to slow progression of the disease, which can eventually lead to kidney failure.

The National Institute for Health and Care Excellence (NICE), which evaluates new treatments and technologies for use on the NHS, approved the drug in December. It drew on the University of Oxford’s EMPA-KIDNEY trial, which was supported by the National Institute for Health and Care (NIHR).

More than 6,600 people participated in the study globally, including 1,133 from the UK and 68 at Oxford University Hospitals NHS Foundation Trust.

The study found that taking a single dose of empagliflozin every day prevents the worsening of kidney diseases or deaths from heart disease in people who have chronic kidney disease.

Empagliflozin is also prescribed to people with type 2 diabetes or heart failure and works by removing excess sugar and salt through the kidneys to prevent deterioration of the organ.

In chronic kidney disease, the kidneys do not work as well as they should. There are usually no symptoms in the early stages and it is diagnosed through a blood or urine test. Causes can include high blood pressure, diabetes or high cholesterol.

About 7.2 million UK people have CKD and treatments include lifestyle changes and medication. Dialysis can be needed to remove waste products and excess fluid from the blood. A kidney transplant may later be required. 

Mr Pickard, 82, from Upper Brailes near Banbury, was diagnosed with reduced kidney function in 2019, after a routine blood test.

Although he did not have any symptoms, the retired property manager asked to join the trial in November 2020 after seeing a poster for the study at the Oxford Kidney Unit at the Churchill Hospital, Oxford. 

He said: “I spoke about the study with my GP and he thought it was worth doing. I thought that if there’s some chance of this helping my condition, then it’s worth it.”

The trial randomly allocated participants to one tablet of empagliflozin daily or a placebo dummy drug. Researchers and participants did not know if they were taking the drug or placebo, to prevent bias. 

They also attended clinics to report on their health and provide blood and urine samples every 6 months over 1 to 4 years.

The grandfather-of-four doesn’t know if he took the drug or a placebo but was prescribed the drug by his GP when it ended.

He said: “I was thrilled to hear that the drug is now available on the NHS for people with this condition and I’m pleased that I played a small part in making that happen.” 

Mr Crane, 76, from Long Hanborough near Witney, was diagnosed in 2010 following a routine check-up for over 60s. John also wasn’t showing signs of the disease when diagnosed. He said: “One of the reasons that I was attracted to the trial was because of the extra tests every 6 months.”

John, a retired television colourist at the BBC, joined the study in 2019 after his GP suggested he volunteer. He said: “When you have to go to the hospital as a patient, it can feel worrying. When you go in for a research study, and there's nothing particularly ‘wrong’ with you, it can be a good laugh. All the nurses were fantastic and we ended up having a lot of fun.”

Although he doesn’t know if he took the drug or not, John’s kidney function stabilised during the trial. He is now taking dapagliflozin, a similar drug to empagliflozin, which also removes excess salt and sugar through the kidneys to improve function.  

John said: “It’s amazing news that the study was such a success. I’m sure that having the drug available on the NHS and more treatment options for people with kidney disease is a positive thing.

“Taking part in this study was a great experience and I’ve since looked to see if there are any other trials I can take part in. Studies like these can not only benefit yourself but can benefit other people too. If anyone is considering taking part in research, I’d say go for it.”

Professor William Herrington, Clinician Scientist at the Medical Research Council Population Health Research Unit at the University of Oxford, and EMPA-KIDNEY trial Chief Investigator, said: “Thanks to the commitment of the trial participants and our collaborators around the world, EMPA-KIDNEY has demonstrated clear results. This NICE guidance should greatly help implementation of these important findings into clinical practice for people living with chronic kidney disease.”

The study was funded by Boehringer Ingelheim Ltd. It opened to recruitment in 2019 and was stopped early due to positive results in 2022.