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Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria

Objective

Patients with diabetes are at risk of developing diabetic nephropathy, which will ultimately result in the requirement for renal replacement therapy and is also associated with high cardiovascular morbidity and mortality. Detection of low concentrations of albuminuria in urine (microalbuminuria) is the current clinical standard for detecting those at significant risk and targeting preventive treatment. However, albuminuria is of low specificity at early stages of disease, and of considerable biological variability, hence a poor predictor at early stages of disease. In two independent studies we have demonstrated that urinary proteomics offers the prospect of detecting nephropathy earlier in the preclinical phase, enabling targeted treatment at an earlier stage. We propose to assess the potential of this technology to identify normoalbuminuric patients at risk and to target therapy with an aldosterone receptor antagonist (spironolactone) as add-on to recommended therapy including angiotensin converting enzyme (ACE) inhibition or angiotensin II receptor blockers (ARBs) according to national guidelines. We will test the following hypotheses: (1) urinary proteomics predicts progression of albuminuria (as a surrogate marker for the development of overt nephropathy) in a cohort of 3280 type 2 diabetic patients with normal urinary albumin excretion, and (2) early initiation of intensive preventive therapy directed by urinary proteomics reduces progression of albuminuria in those 20 % at high risk and thereby delay progression to overt nephropathy and spare treatment for those with low risk, paving the way of personalised medicine. This will be the first biomarker-directed therapy trial for primary prevention of diabetic kidney disease. Additional clinical and circulating biomarkers will be assessed and models to predict progression of albuminuria including clinical factors, biomarkers and proteomics will be developed.
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Coordinator

REGION HOVEDSTADEN

Address

Kongens Vaenge 2
3400 Hillerod

Denmark

Activity type

Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)

EU Contribution

€ 438 930,70

Administrative Contact

Maria Athena Campbell (Mrs.)

Participants (21)

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MOSAIQUES DIAGNOSTICS GMBH

Germany

EU Contribution

€ 1 499 250

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

EU Contribution

€ 210 201

UNIVERSITY OF GLASGOW

United Kingdom

EU Contribution

€ 963 920,40

ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Italy

EU Contribution

€ 283 830

UNIVERZITA KARLOVA

Czechia

EU Contribution

€ 82 080

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany

EU Contribution

€ 6 686,30

GENIKO NOSOKOMEIO ATHINAS IPPOKRATEIO

Greece

EU Contribution

€ 84 570

Institut klinické a experimentální mediciny

Czechia

EU Contribution

€ 64 940

INSTITUTO INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ

Spain

EU Contribution

€ 25 639,50

RD NEPHROLOGIE SAS

France

EU Contribution

€ 9 804,80

KLINIKUM ST GEORG GGMBH

Germany

EU Contribution

€ 66 740

UNIVERSITAT ZURICH

Switzerland

Ss. CYRIL AND METHODIUS UNIVERSITY IN SKOPJE

North Macedonia

EU Contribution

€ 178 250,25

HANNOVER CLINICAL TRIAL CENTER GMBH

Germany

EU Contribution

€ 850 550,90

DIABETES AND VASCULAR RESEARCH FOUNDATION

Netherlands

EU Contribution

€ 30 890

Universitair Ziekenhuis Gent

Belgium

EU Contribution

€ 66 259,99

GWT-TUD GMBH

Germany

EU Contribution

€ 25 910

STICHTING VU

Netherlands

DIABETOLOGEN HESSEN EG

Germany

EU Contribution

€ 61 740

STICHTING VUMC

Netherlands

EU Contribution

€ 149 958

Steno Diabetes Center A/S

Denmark

EU Contribution

€ 880 348,16

Project information

Grant agreement ID: 279277

Status

Closed project

  • Start date

    1 January 2012

  • End date

    31 December 2018

Funded under:

FP7-HEALTH

  • Overall budget:

    € 8 649 785,94

  • EU contribution

    € 5 980 500

Coordinated by:

REGION HOVEDSTADEN

Denmark