General information
for patients
BEAt-DKD (“Biomarker Enterprise to Attack Diabetic Kidney Disease”) is a unique collaboration between public and private sectors, with the aim to improve prevention and management of DKD, the most common form of chronic kidney disease. Presently, there are no means to effectively prevent or cure DKD, which has reached epidemic dimensions and is the leading cause of end-stage renal disease (ESRD)End-stage renal disease (ESRD):
Kidney failure treated
by dialysis or a kidney transplant and kidney failureKidney failure:
Kidney damage that is so advanced that less than 15% of your kidney works normally. It is a debilitating disease, with patients facing mortalities exceeding most cancers while being underserved by inefficient and unsuccessful drug development. DKD remains a large unmet medical need.
BEAt-DKD is a 5-year project jointly funded by the European Union's Innovative Medicines Initiative (IMI), member companies from the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Juvenile Diabetes Research Foundation (JDRF) and the Swiss state. It has gathered leading experts from 22 academic institutions and hospitals, 7 EFPIA pharmaceutical companies, 1 biotech company and a patient organization, with the goal to identify mechanisms and pathways underlying initiation, progression and heterogeneity of DKD that can be targets for new treatments, as well as to identify and validate biomarkers of disease progression and treatment responses.
Main focus in the BEAt-DKD project is the discovery and implementation of different kinds of biomarkers. A biomarker can be a substance measured in blood or urine, or something detectable in an image, which can give us important information about the underlying mechanisms in DKD and which can e.g. predict the risk of developing DKD or how a patient will respond to a given treatment. A biomarker should be relatively easy to measure in order to be used in clinical practice.
We expect to:
significantly advance understanding of the heterogeneity of DKD and the processes that underlie the disease, by integrating knowledge and techniques from different medical disciplines
optimally explore existing and new information by using state-of-the-art techniques, to better understand how to translate data from animal and cell models into knowledge relevant for the disease in humans
by building on the broad experience within BEAt-DKD and involving expert advice from regulatory agencies and other stakeholders, facilitate the development of standardized sets of biomarkers with both prognosticPrognostic:
Indicating the likelihood of patient outcome, regardless of a specific treatment. and predictive Predictive:
Indicating the likelihood of benefitting from a specific treatment.capacity to serve as criteria for decision on the use of future clinical trial protocols for evaluating novel therapies for DKD
contribute to a better stratification of diabetes patients, which will allow a division of patients into subgroups with specific characteristics
improve conditions for development of new therapies for DKD, with a better patient stratification and the new biomarkers leading to a reduction in numbers of patients needed to be included in clinical trials, thus more rapidly providing evidence for a new treatment, which in turn will allow a faster submission for regulatory approval
take first steps towards precision medicine in DKD: treatment tailored to the individual needs of the patient
The iBEAt study, led by Work Package 4 (WP 4 – Development, identification, and validation of prognostic and predictive imaging biomarkers), is a patient-based study examining whether imaging of the kidneys by MRI or ultrasound provide insight, above standard clinical measures from blood and urine, into how diabetic kidney disease develops and why/how it varies between individuals with diabetes. For example, can the imaging biomarkers identify individuals at higher risk of diabetic kidney disease?
The iBEAt study has recruited over 500 participants with type 2 diabetes, and a smaller group of individuals with type 1 diabetes, with either no or early signs of kidney changes from 6 different study centers across the UK, Italy, Finland, and France. At the start of the study, each participant undergoes MRI and ultrasound imaging of their kidneys as well as a medical examination, standard clinical measurements (e.g. blood pressure) and collection of iBEAt blood and urine samples. The medical examination, standard clinical measurements and collection of blood and urines samples are repeated every year for 3 years. Some of the collected blood and urine is sent to the local hospital laboratories for standard clinical tests, whilst the rest of the samples are stored for later more specialized measurements, including measurements at the central laboratory in Sweden.
In the videos below, the journey of the biofluid tubes used for the samples is described. You can follow the tubes from the central site in Sweden, out to the various centers for sample collection, to the technicians for processing, and back to Sweden for analyses. You will be able to see everything from how the sample tubes are labelled to ensure anonymity for participants to detailed descriptions of how the technicians process the samples.
In the PowerPoint presentation below, you can learn more about what the iBEAT study entails and what the different centers do.
View presentaton