Scientific research

Diaverum’s scientific research philosophy is based on the needs and the demands of the patients. Led by Scientific Director Giovanni FM Strippoli, we are increasingly active in world-class clinical research with a strong patient focus, to improve our practices and understanding of the complex needs of renal patients.

Studies have found that the main areas which renal patients consider as research priorities are related to the normalisation of their daily lives, despite their illness. Patients demand research on prevention, complications and symptoms, dialysis and transplantation, and, particularly, research that takes into consideration psychological factors and the well-being of the entire body. Diaverum’s patient-centred research focuses on preventing or minimising the risks for dialysis, making dialysis more effective, finding solutions to minimise risks of dialysis side effects, and finding proof that dialysis related drugs have a real positive effect.

Current studies

Anaemia

CEDOSE is a comparative multicentre randomised trial which compares two fixed doses of erythropoiesis stimulating agents (ESA), drugs used for the management of anaemia, in people who are on dialysis. This study will enrol 900 people on haemodialysis and follow them for approximately four one year, to measure the benefits and harms of a high and a low dose of these drugs. It is performed in Italy and funded by the Italian Agency for Drugs, a governmental body which funds independent research on drugs.

Cardiovascular risk

LIRICO is a comparative multicentre randomised trial which compares the use of ACE-inhibitors, angiotensin receptor blockers and their combination in people with microalbuminuria (leakage

of small amounts of the protein albumin from the kidney into the urine) and one or more cardiovascular risk factors. These people, if not treated, are at risk of major cardiovascular events, death or end stage kidney disease requiring dialysis or transplantation. This study has enrolled 1,300 people with microalbuminuria and cardiovascular risk and is currently following them for a total follow-up of four years, to measure the benefits and harms of these drugs. This study is also performed in Italy and funded by the Italian Agency for Drugs.

Sexual dysfunction and depression

CDS is the largest worldwide cross-sectional study which looks at the prevalence of depression and sexual dysfunction in people on haemodialysis. The study also looks at factors in dialysis clinical

performance and socio-economic circumstances that can indicate that a patient may have a depression or a sexual dysfunction. The study is now completed and data on erectile dysfunction and female sexual dysfunction have been published in major international renal journals. Additional analyses of other results are going to be published in the forthcoming years. More than 3,000 people on haemodialysis participated in the study, which was primarily funded by Diaverum.

Oral diseases

ORAL-D is the largest worldwide cross-sectional and prospective cohort study which looks at the prevalence of dental, periodontal, oral mucosa and salivary gland abnormalities in people on haemodialysis. The study also evaluated the association of these lesions with hospitalisations and mortality in haemodialysis. It is currently completed at a multinational level in Diaverum clinics and data on prevalence are being analysed. Follow-up will be completed in 2013 and data on association with major adverse vascular outcomes will also be analysed. Approximately 5,000 people on haemodialysis have been involved in the study, which represents a major public health effort in the interest of prevention of oral lesions and associated risk of adverse events. The study is primarily funded by Diaverum.

Nutrition

The Diaverum nutrition study is the largest worldwide prospective cohort study exploring the nutritional patterns of people with end stage kidney disease, and their association with mortality and major adverse cardio-cerebrovascular events. The study is currently starting. More than 5,000 people on haemodialysis will participate in the study, which is a major public health effort in the interest of prevention of major adverse vascular events in these patients. The study is primarily funded by Diaverum.

Publications

Diaverum studies have been published in numerous distinguished medical publications, both nephrology journals and internal medicine journals. The former include the Journal of the American Society of Nephrology, Kidney International, American Journal of Kidney Diseases and Nephrology Dialysis and Transplantations. We are also featured in the New England Journal of Medicine, Lancet, Annals of Internal Medicine, British Medical Journal, the Cochrane Database of Systematic Reviews and Plos Medicine.