Diabetic nephropathy

  1. DiaPat® DN-PROteom test: Diabetes patients, take care of your kidneys!
  2. DiaPat® DN-PROteom test: How does this work? What can the test do?
  3. Diabetic Nephropathy: What should I know?
  4. Early detection step by step: our expert advice
  5. DiaPat® DN-PROteom test: How can I have this done?
  6. DiaPat® DN-PROteom test: Trust is good. Control is better.
  7. DiaPat® DN-PROteom test: The path to the statutory health insurance system is paved.

DiaPat® DN-PROteom test: Diabetes patients, take care of your kidneys!

The DiaPat® DN-PROteom test is the extremely reliable, non-invasive method for type I and type II diabetics to diagnose diabetic nephropathy (DN). DN as a complication of diabetes is gaining momentum. Previous preventive measures of the statutory health insurance could neither contain the dynamic nor achieve any other measurable success. The New England Journal of Medicine reported in a 20-year long-term study of irrelevant containment of the secondary disease of DN:

Gregg,E.W., Li,Y., Wang,J., Burrows,N.R., Ali,M.K., Rolka,D., Williams,D.E., and Geiss,L. (2014). Changes in diabetes-related complications in the United States, 1990-2010. N. Engl. J Med 370, 1514-1523.

The DiaPat® DN-PROteom test detects kidney disease years before current standards and the appearance of the first clinical symptoms due to irreparable kidney damage.

Your kidney insurance for a healthier, longer life.

Used at an early stage, the test for diabetics is a kind of insurance for the preservation of their kidneys and a longer, healthy life without dialysis. The DiaPat® DN-PROteom test can also be used to demonstrate the monitoring of an immediately applied individual drug therapy for already diseased kidneys.



DiaPat® DN-PROteom test: How does this work? What can the test do?

The DiaPat® DN-PROteom test analyzes 273 disease-specific proteins in the urine. He compares the result with a pattern of disease-specific proteins, biomarkers for diabetic nephropathy. In this way, the test detects chronic kidney disease 3-5 years before the first clinical symptom, and it does so with the utmost reliability (sensitivity [gr]85%, specificity [gr]85%)), earlier and more precisely than standard methods previously used: determination the albumin excretion or the GFR.

The early detection of diabetic nephropathy, which is possible with the DiaPat® DN-PROteom test, usually prevents fatal kidney failure or kidney replacement therapy (dialysis or kidney transplantation). Because an immediately applied drug therapy still has the chance to significantly improve the prognosis at this early stage of the disease. This means slowing down the progression of the disease or even preventing serious damage to the kidneys entirely.



Diabetic Nephropathy: What should I know?

Diabetic nephropathy is a frequently occurring kidney disease, a kidney disease as a result of long-term, not optimally controlled diabetes (diabetes mellitus type I, type II). An average of 10 to 15 years after the onset of their diabetes, 25% to 40% of diabetics suffer from this insidious kidney dysfunction. In Germany, diabetic nephropathy is the most common cause of kidney failure requiring dialysis.

Background: Diabetes mellitus is a chronic metabolic disease that causes high blood sugar. Reasons for this can be a lack of insulin (type I) or a lack of sensitivity of the body cells to insulin (type II). As a result, the body cannot fully absorb sugary foods (bread, pasta, rice, desserts). The contained sugar accumulates in the blood. This leads to an increased concentration of blood sugar and harmful deposits in the body's blood vessel system, including the kidney corpuscles, which serve as filters there.

Just as in general, the blood pressure in the kidney corpuscles also rises due to calcification of the renal arteries. The kidney's natural filtering function gradually fails. The doctor speaks of this kidney disease as diabetic nephropathy. If left untreated, it leads to approx. 2.5 years to chronic kidney failure. The diagnostic challenge here: the onset of nephropathy does not cause pain and is symptom-free, unnoticed.

Other risk factors for diabetic nephropathy: high blood pressure, age, family history, smoking, obesity.


Early detection step by step: our expert advice

Diabetic nephropathy is usually detected in clinical practice on the basis of albuminuria and/or an altered glomerular filtration rate (GFR). However, these common methods often do not respond until the filtration capacity of the renal corpuscles is already impaired. At this point, the kidney is already irreparably damaged.

Professor Dr. Dr. Diethelm Tschöpe, Heart and Diabetes Center NRW:
"For the first time, diabetic nephropathy can be diagnosed at an early stage with the DiaPat® DN-PROteom test and treated accordingly. For the patient, this reliable diagnostic method means a decisive advance in treatment time."

Professor Dr. Peter Rossing, Steno Diabetes Center, Gentofte/Kopenhagen:
"The early use of drug therapy increases the efficiency of the kidneys and prevents kidney replacement therapy. The effects of the therapy can be optimally checked with the DiaPat® DN-PROteom test."

DiaPat® DN-PROteom test: How can I have this done?

To order your DiaPat® DN-PROteom test, simply call us on (0511) 55 47 44 0 or ask your doctor.

In any case, the test is very easy to carry out: you give a urine sample to the doctor you trust, which is then cooled and sent to us by overnight express.

We will send you or your doctor everything you need in advance with your DiaPat® test package. We also explain all the details that we ask you for so that the test delivers a reliable result for you.

DiaPat® DN-PROteom test: Trust is good. Control is better.

The DiaPat® DN-PROteom test has been validated in clinical studies:

Pontillo C, Jacobs L, Staessen JA, Schanstra JP, Rossing P, Heerspink HJ, Siwy J, Mullen W, Vlahou A, Mischak H, Vanholder R, Zürbig P, Jankowski J.
A urinary proteome-based classifier for the early detection of decline in glomerular filtration.Nephrol Dial Transplant. 2016 Jul 6. pii: gfw239. [Epub ahead of print]

Critselis E, Lambers Heerspink H.
Utility of the CKD273 peptide classifier in predicting chronic kidney disease progression.Nephrol Dial Transplant. 2016 Feb;31(2):249-54. doi: 10.1093/ndt/gfv062. Epub 2015 Mar 19.

Øvrehus MA, Zürbig P, Vikse BE, Hallan SI.
Urinary proteomics in chronic kidney disease: diagnosis and risk of progression beyond albuminuria.Clin Proteomics. 2015 Aug 7;12(1):21. doi: 10.1186/s12014-015-9092-7. eCollection 2015.

Schanstra JP, Zürbig P, Alkhalaf A, Argiles A, Bakker SJ, Beige J, Bilo HJ, Chatzikyrkou C, Dakna M, Dawson J, Delles C, Haller H, Haubitz M, Husi H, Jankowski J, Jerums G, Kleefstra N, Kuznetsova T, Maahs DM, Menne J, Mullen W, Ortiz A, Persson F, Rossing P, Ruggenenti P, Rychlik I, Serra AL, Siwy J, Snell-Bergeon J, Spasovski G, Staessen JA, Vlahou A, Mischak H, Vanholder R.
Diagnosis and Prediction of CKD Progression by Assessment of Urinary Peptides.J Am Soc Nephrol. 2015 Aug;26(8):1999-2010. doi: 10.1681/ASN.2014050423. Epub 2015 Jan 14.

Siwy J, Schanstra JP, Argiles A, Bakker SJ, Beige J, Boucek P, Brand K, Delles C, Duranton F, Fernandez-Fernandez B, Jankowski ML, Al Khatib M, Kunt T, Lajer M, Lichtinghagen R, Lindhardt M, Maahs DM, Mischak H, Mullen W, Navis G, Noutsou M, Ortiz A, Persson F, Petrie JR, Roob JM, Rossing P, Ruggenenti P, Rychlik I, Serra AL, Snell-Bergeon J, Spasovski G, Stojceva-Taneva O, Trillini M, von der Leyen H, Winklhofer-Roob BM, Zürbig P, Jankowski J.
Multicentre prospective validation of a urinary peptidome-based classifier for the diagnosis of type 2 diabetic nephropathy.Nephrol Dial Transplant. 2014 Aug;29(8):1563-70. doi: 10.1093/ndt/gfu039. Epub 2014 Mar 2.

Argilés Á, Siwy J, Duranton F, Gayrard N, Dakna M, Lundin U, Osaba L, Delles C, Mourad G, Weinberger KM, Mischak H.
CKD273, a new proteomics classifier assessing CKD and its prognosis.PLoS One. 2013 May 14;8(5):e62837. doi: 10.1371/journal.pone.0062837. Print 2013.

Roscioni SS, de Zeeuw D, Hellemons ME, Mischak H, Zürbig P, Bakker SJ, Gansevoort RT, Reinhard H, Persson F, Lajer M, Rossing P, Lambers Heerspink HJ.
A urinary peptide biomarker set predicts worsening of albuminuria in type 2 diabetes mellitus.Diabetologia. 2013 Feb;56(2):259-67. doi: 10.1007/s00125-012-2755-2. Epub 2012 Oct 20.

Zürbig P, Jerums G, Hovind P, MacIsaac R, Mischak H, Nielsen SE, Panagiotopoulos S, Persson F, Rossing P.
Urinary Proteomics for Early Diagnosis in Diabetic Nephropathy.Diabetes. 2012 Dec;61(12):3304-13. doi: 10.2337/db12-0348. Epub 2012 Aug 7.

David M. Good, Petra Zurbig, Hartwig W. Bauer,Georg Behrens, Joshua J. Coon,a,i Mohammed Dakna, Stephane Decramer,Christian Delles, Anna F. Dominiczak,Jochen H. H. Ehrich, Frank Eitner, Danilo Fliser, Moritz Frommberger,r Arnold Ganser,s Mark A. Girolami, Igor Golovko,c Wilfried Gwinner,u Marion Haubitz,u Stefan Herget-Rosenthal, Joachim Jankowski, Holger Jahn,y George Jerums,z Bruce A. Julian, Markus Kellmann, Volker Kliem, Walter Kolch, Andrzej S. Krolewski, Mario Luppi,hh Ziad Massy, Michael Melter, Christian Neusu, Jan Novak,Karlheinz Peter, Kasper Rossing,mm Harald Rupprecht,nn Joost P. Schanstra, Eric Schiffer,Jens-Uwe Stolzenburg, Lise Tarnow, Dan Theodorescu, Visith Thongboonker, Raymond Vanholder, Eva M. Weissinger,Harald Mischak,and Philippe Schmitt-Kopplinr
Naturally Occurring Human Urinary Peptides for Use in Diagnosis of Chronic Kidney Disease© 2010 by The American Society for Biochemistry and Molecular Biology, Inc.
This paper is available on line at http://www.mcponline.org


In the meantime, it has also been proven that an earlier, intensive treatment can achieve significant therapeutic success if an earlier, reliable diagnosis can be made. Studies have shown that with the earlier detection of the DN and the more intensive treatment associated with it, the further progression of the DN can be stopped significantly, at least for a relevant period of time. With traditional diagnostics - especially the measurement of a single protein (the albumin protein content in urine) - the DN is recognized late. Often so late that pathological functional disorders or organ damage are irreversibly far advanced. The DiaPat® DN-PROteom test with 273 proteins / protein fragments, on the other hand, can detect diabetic nephropathy in its very early stages - up to 2 years earlier and more precisely than microalbuminuria.

Andresdottir,G., Jensen,M.L., Carstensen,B., Parving,H.H., Rossing,K., Hansen,T.W., and Rossing,P. (2014). Improved survival and renal prognosis of patients with type 2 diabetes and nephropathy with improved control of risk factors. Diabetes Care 37, 1660-1667.

Farmer,A.J., Stevens,R., Hirst,J., Lung,T., Oke,J., Clarke,P., Glasziou,P., Neil,A., Dunger,D., Colhoun,M., Pugh,C., Wong,G., Perera,R., and Shine,B. (2014). Optimal strategies for identifying kidney disease in diabetes: properties of screening tests, progression of renal dysfunction and impact of treatment - systematic review and modelling of progression and cost-effectiveness. Health Technol. Assess. 18, 1-128.

Good,D.M., Zürbig,P., Argiles,A., Bauer,H.W., Behrens,G., Coon,J.J., Dakna,M., Decramer,S., Delles,C., Dominiczak,A.F., Ehrich,J.H., Eitner,F., Fliser,D., Frommberger,M., Ganser,A., Girolami,M.A., Golovko,I., Gwinner,W., Haubitz,M., Herget-Rosenthal,S., Jankowski,J., Jahn,H., Jerums,G., Julian,B.A., Kellmann,M., Kliem,V., Kolch,W., Krolewski,A.S., Luppi,M., Massy,Z., Melter,M., Neususs,C., Novak,J., Peter,K., Rossing,K., Rupprecht,H., Schanstra,J.P., Schiffer,E., Stolzenburg,J.U., Tarnow,L., Theodorescu,D., Thongboonkerd,V., Vanholder,R., Weissinger,E.M., Mischak,H., and Schmitt-Kopplin,P. (2010). Naturally occurring human urinary peptides for use in diagnosis of chronic kidney disease. Mol. Cell Proteomics 9, 2424-2437.

Roscioni,S.S., de,Z.D., Hellemons,M.E., Mischak,H., Zurbig,P., Bakker,S.J., Gansevoort,R.T., Reinhard,H., Persson,F., Lajer,M., Rossing,P., and Heerspink,H.J. (2012). A urinary peptide biomarker set predicts worsening of albuminuria in type 2 diabetes mellitus. Diabetologia 56, 259-267.

Argiles,A., Siwy,J., Duranton,F., Gayrard,N., Dakna,M., Lundin,U., Osaba,L., Delles,C., Mourad,G., Weinberger,K.M., and Mischak,H. (2013). CKD273, a New Proteomics Classifier Assessing CKD and Its Prognosis. PLoS One 8, e62837.

Schanstra, J. P., Zürbig, P., Alkhalaf, A., Argiles, A., Bakker , S. J. L., Beige, J., Bilo, H. J. G., Chatzikyrkou, C, Dakna, M., Dawson, J., Delles, C., Haller, H., Haubitz, M., Husi, H., Jankowski, J., Jerums, G., Kleefstra, N., Kuznetsova, T., Maahs, D., Menne, J., Mullen, W., Ortiz, A., Persson, F., Rossing, P., Ruggenenti, P., Rychlik, I., Serra, A. L., Siwy, J., Snell-Bergeon, J., Spasovski, G., Staessen, J. A., Vlahou, A., Mischak, H., and Vanholder, R. Diagnosis and Prediction of CKD Progression by Assessment of Urinary Peptides. J Am.Soc.Nephrol. in press. 2014.

Zürbig,P., Jerums,G., Hovind,P., MacIsaac,R., Mischak,H., Nielsen,S.E., Panagiotopoulos,S., Persson,F., and Rossing,P. (2012). Urinary Proteomics for Early Diagnosis in Diabetic Nephropathy. Diabetes 61, 3304-3313

DiaPat® DN-PROteom test: The path to the statutory health insurance system is paved.

By application of the National Association of Statutory Health Insurance Physicians (KBV) from 07/07/2011, the evaluation of the "proteome analysis in urine for the detection of diabetic nephropathy in patients with diabetes mellitus and arterial hypertension" according to § 135 paragraph 1 SGB V was applied for. After submitting the application on December 20, 2012, the Federal Joint Committee (G-BA) decided to commission the Institute for Quality and Efficiency in Health Care (IQWiG) with the assessment. The G-BA published the advisory topic on December 29, 2012 in the Federal Gazette in order to give experts and experts the opportunity to comment.