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Nephrol Dial Transplant. 2014 Aug;29(8):1563-70. doi: 10.1093/ndt/gfu039. Epub 2014 Mar 2.

Multicentre prospective validation of a urinary peptidome-based classifier for the diagnosis of type 2 diabetic nephropathy.

Author information

1
Mosaiques Diagnostics GmbH, Hanover, Germany Charité-Universitaetsmedizin Berlin, Medizinische Klinik IV, Berlin, Germany.
2
Mosaiques Diagnostics GmbH, Hanover, Germany Institut National de la Santé et de la Recherche Médicale (INSERM), U1048, Institut of Cardiovascular and Metabolic Disease, Toulouse, France Université Toulouse III Paul-Sabatier, Toulouse, France.
3
RD Néphrologie, Montpellier, France Néphrologie Dialyse St Guilhem, Sète, France Service de Néphrologie, Dialyse Péritonéale et Transplantation, Montpellier, France.
4
Department of Internal Medicine, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands.
5
Department of Nephrology and KfH Renal Unit, Hospital St. Georg, Leipzig, Germany.
6
Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
7
Institut für Klinische Chemie, Medizinische Hochschule Hannover, Hannover, Germany.
8
BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.
9
RD Néphrologie, Montpellier, France.
10
IIS-Fundacion Jimenez Diaz/UAM/IRSIN and REDIREN, Madrid, Spain.
11
Charité-Universitaetsmedizin Berlin, Medizinische Klinik IV, Berlin, Germany.
12
HealthPlus Diabetes & Endocrinology Center, Abu Dhabi, UAE.
13
Steno Diabetes Center, Gentofte, Denmark.
14
Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, USA.
15
Mosaiques Diagnostics GmbH, Hanover, Germany BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.
16
Department of Internal Medicine, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands Department of Clinical Pharmacology, University Medical Center Groningen, Groningen and University of Groningen, The Netherlands.
17
Diabetes Center, Second Department of Medicine, Athens University Medical School, Hippokration Hospital, Athens, Greece.
18
Clinical Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
19
Steno Diabetes Center, Gentofte, Denmark HEALTH, University of Aarhus, Aarhus, Denmark Faculty of Health, University of Copenhagen, Copenhagen, Denmark.
20
IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Clinical Research Center for Rare Diseases 'Aldo e Cele Daccò', Bergamo, Italy Unit of Nephrology and Dialysis, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
21
Second Department of Internal Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.
22
Division of Nephrology, University Hospital, Zürich, Switzerland.
23
Department of Nephrology, University of Skopje, Skopje, Macedonia.
24
IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Clinical Research Center for Rare Diseases 'Aldo e Cele Daccò', Bergamo, Italy.
25
Hannover Clinical Trial Center, Hannover, Germany.
26
Human Nutrition & Metabolism Research and Training Center, Institute of Molecular Biosciences, Karl-Franzens University of Graz, Graz, Austria.
27
Mosaiques Diagnostics GmbH, Hanover, Germany.

Abstract

BACKGROUND:

Diabetic nephropathy (DN) is one of the major late complications of diabetes. Treatment aimed at slowing down the progression of DN is available but methods for early and definitive detection of DN progression are currently lacking. The 'Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria trial' (PRIORITY) aims to evaluate the early detection of DN in patients with type 2 diabetes (T2D) using a urinary proteome-based classifier (CKD273).

METHODS:

In this ancillary study of the recently initiated PRIORITY trial we aimed to validate for the first time the CKD273 classifier in a multicentre (9 different institutions providing samples from 165 T2D patients) prospective setting. In addition we also investigated the influence of sample containers, age and gender on the CKD273 classifier.

RESULTS:

We observed a high consistency of the CKD273 classification scores across the different centres with areas under the curves ranging from 0.95 to 1.00. The classifier was independent of age (range tested 16-89 years) and gender. Furthermore, the use of different urine storage containers did not affect the classification scores. Analysis of the distribution of the individual peptides of the classifier over the nine different centres showed that fragments of blood-derived and extracellular matrix proteins were the most consistently found.

CONCLUSION:

We provide for the first time validation of this urinary proteome-based classifier in a multicentre prospective setting and show the suitability of the CKD273 classifier to be used in the PRIORITY trial.

KEYWORDS:

biomarkers; chronic kidney disease; diabetic nephropathy; diagnosis; urine proteomics

PMID:
24589724
PMCID:
PMC4118140
DOI:
10.1093/ndt/gfu039
[Indexed for MEDLINE]
Free PMC Article
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