Kidney Week

Abstract: FR-PO424

Prognostic Imaging Biomarkers for Diabetic Kidney Disease (iBEAT): A BEAt-DKD Study

Session Information

• Diabetic Kidney Disease: Clinical - I
  October 26, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 602 Diabetic Kidney Disease: Clinical

Authors

• Sourbron, Steven, University of Leeds, Leeds, United Kingdom

Steven Sourbron,

• Gooding, Kim, University of Exeter Medical School, Exeter, United Kingdom

Kim Gooding,

• Lienczewski, Chrysta C., University of Michigan Medical Center, Ann Arbor, Michigan, United States

Chrysta C. Lienczewski,

• Papale, Massimo, University of Bari, Bari, Italy

Massimo Papale,

• Koivuviita, Niina S., Hospital District of Southwest Filand, Turku, Finland

Niina S. Koivuviita,

• Zetterqvist, Anna V., Lund University, Malmö, Sweden

Anna V. Zetterqvist,

• Andersson, Anna-Maria Dutius, Lund University, Malmö, Sweden

Anna-Maria Dutius Andersson,

• Sharma, Kanishka, University of Leeds, Leeds, United Kingdom

Kanishka Sharma,

• Garcia-Hernandez, Alberto, Astellas Pharma Europe B.V., Leiden, Netherlands

Alberto Garcia-Hernandez,

• Kuznetsov, Dmitry, SIB, Lausanne, Switzerland

Dmitry Kuznetsov,

• Saunavaara, Virva, Turku PET centre c/o Turku University Hospital, Turku, Finland

Virva Saunavaara,

• Tagkalakis, Fotios, University of Leeds, Leeds, United Kingdom

Fotios Tagkalakis,

• Pesce, Francesco, University of Bari, Bari, Italy

Francesco Pesce,

• Teh, Irvin, University of Leeds, Leeds, United Kingdom

Irvin Teh,

• Ball, Claire, NIHR Exeter Clinical Research Facility, Exeter, United Kingdom

Claire Ball,

• Puppala, Sapna, Leeds teaching hospital, Leeds, United Kingdom

Sapna Puppala,

• Metsarinne, Kaj P., Turku University Central Hospital, Turku, Finland

Kaj P. Metsarinne,

• Combe, Christian, CHU de Bordeaux, Bordeaux, France

Christian Combe,

• Ibberson, Mark, SIB, Lausanne, Switzerland

Mark Ibberson,

• Holthofer, Harry B., University of Helsinki, Finnish Institute of Molecular Medicine, Helsinki, Finland

Harry B. Holthofer,

• Simons, Kai, MPI-CBG, Dresden, Germany

Kai Simons,

• Karihaloo, Anil K., Novo Nordisk, Seattle, Washington, United States

Anil K. Karihaloo,

• Ju, Wenjun, University of Michigan, Ann Arbor, Michigan, United States

Wenjun Ju,

• Urquhart, Richard, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, United States

Richard Urquhart,

• Rigalleau, Vincent, CHU de Bordeaux, Bordeaux, France

Vincent Rigalleau,

• Banks, Rosamonde Elizabeth, University of Leeds, Leeds, United Kingdom

Rosamonde Elizabeth Banks,

• Gilmour, Peter S., Astellas Pharma Europe BV, Leiden, Netherlands

Peter S. Gilmour,

• Mansfield, Michael W., University of Leeds, Leeds, United Kingdom

Michael W. Mansfield,

• Gilchrist, Mark, Royal Devon and Exeter Hospital, Devon, Exeter, United Kingdom

Mark Gilchrist,

• de Zeeuw, Dick, University Medical Center Groningen, Groningen, Netherlands

Dick de Zeeuw,

• Lambers Heerspink, Hiddo Jan, University Medical Center Groningen, Groningen, Netherlands

Hiddo Jan Lambers Heerspink,

• Kretzler, Matthias, U.Michigan, Ann Arbor, Michigan, United States

Matthias Kretzler,

• Welberry smith, Matthew, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

Matthew Welberry smith,

• Gesualdo, Loreto, University of Bari, Bari, Italy

Loreto Gesualdo,

• Andress, Dennis L., AbbVie, North Chicago, Illinois, United States

Dennis L. Andress,

• Grenier, Nicolas, Pellegrin Hospital, Bordeaux, France

Nicolas Grenier,

• Shore, Angela C., University of Exeter, Exeter, United Kingdom

Angela C. Shore,

• Gomez, Maria F., Lund University, Malmö, Sweden

Maria F. Gomez,

Background

BEAt-DKD (Biomarker Enterprise to Attack DKD) is a public-private partnership committed to deliver more effective patient stratification, DKD prevention and management (www.beat-dkd.eu; IMI-JU No 115974). We report here on an early milestone in BEAt-DKD, the design and setup of a clinical study (iBEAT) to explore the utility of imaging biomarkers.

Methods

iBEAT was developed as a collaborative project with central coordination between sept 2016 and June 2018. iBEAT will be run by 7 core sites including 5 recruiting centres, one of whom is the coordinating site (Leeds), a central biobank (Lund), a data management centre (Lausanne), and an image processing and QA centre (Leeds)

Results

iBEAT is a 4-year prospective observational cohort study in 500 patients with Type 2 diabetes and eGFR>30mL/min, aiming to identify MRI & Ultrasound (US) biomarkers that can improve DKD prognosis. MRI and US will be collected at baseline only. Demographics, clinical, family and medication history, blood (70mL) and urine will be collected annually.
Additional data will be collected by four sites to address ancillary objectives (100 patients per site): Kidney biopsies, digitalized and characterized by histology and EM (Bari); PET-based renal blood flow (Turku); glycocalyx and microvascular assessments (Exeter); 2-year follow-up MRI and US (Bordeaux).
Biopsies and biofluids including urinary vesicles and sediment will be used for biomarker discovery using state of the art omics, and stored for validation studies. A parsimonious set of baseline biomarkers associated with eGFR (primary) and eGFR slope over time (secondary) will be identified.

Conclusion

iBEAT is the largest functional imaging biomarker study in DKD performed to date. The study will test the utility of imaging biomarkers for DKD prognosis, and may also help improve our understanding of disease pathogenesis.

Funding

• Commercial Support – European Federation of Pharmaceutical Industries and Associations