Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice?
Diabetic kidney disease (DKD) is a complex and multifactorial disorder associated with deregulations in a large number of different biological pathways on the molecular level. Using the 2 established biomarkers, estimated glomerular filtration rate (eGFR) and albuminuria will not allow allocating pa...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2019-02-01
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| Series: | Kidney International Reports |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468024918303437 |
| _version_ | 1819163544568987648 |
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| author | Paul Perco Michelle Pena Hiddo J.L. Heerspink Gert Mayer |
| author_facet | Paul Perco Michelle Pena Hiddo J.L. Heerspink Gert Mayer |
| author_sort | Paul Perco |
| collection | DOAJ |
| description | Diabetic kidney disease (DKD) is a complex and multifactorial disorder associated with deregulations in a large number of different biological pathways on the molecular level. Using the 2 established biomarkers, estimated glomerular filtration rate (eGFR) and albuminuria will not allow allocating patients to tailored therapy. Molecular multimarker panels as sensors for the deregulation of the various disease mechanisms combined with a better understanding of how investigational as well as approved drugs interfere with these disease processes forms the basis for platform trials in DKD. In these platform trials, patients with DKD are assigned to the most suitable treatment arm based on their molecular marker profile. Close monitoring of biomarkers after treatment initiation together with assessment of renal function and “off-target” effects will allow identification of therapy responders, with nonresponders shifted to the next-best treatment arm based on their molecular profile. In this viewpoint article, we summarize evidence on the variation of DKD disease progression as well as the response to therapy and outline procedures to model disease pathophysiology supporting biomarker panel construction. Finally, the use of biomarkers in clinical trial setup is discussed. Keywords: biomarker panel, clinical trial design, diabetic kidney disease, pathophysiology, predictive marker |
| first_indexed | 2024-12-22T17:45:49Z |
| format | Article |
| id | doaj.art-7b2292e617664aecbe56656f0634b646 |
| institution | Directory Open Access Journal |
| issn | 2468-0249 |
| language | English |
| last_indexed | 2024-12-22T17:45:49Z |
| publishDate | 2019-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney International Reports |
| spelling | doaj.art-7b2292e617664aecbe56656f0634b6462022-12-21T18:18:18ZengElsevierKidney International Reports2468-02492019-02-0142212221Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice?Paul Perco0Michelle Pena1Hiddo J.L. Heerspink2Gert Mayer3Department of Internal Medicine IV (Nephrology and Hypertension), Medical University Innsbruck, Innsbruck, AustriaDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the NetherlandsDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the NetherlandsDepartment of Internal Medicine IV (Nephrology and Hypertension), Medical University Innsbruck, Innsbruck, Austria; Correspondence: Gert Mayer, Department of Internal Medicine IV (Nephrology and Hypertension), Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria.Diabetic kidney disease (DKD) is a complex and multifactorial disorder associated with deregulations in a large number of different biological pathways on the molecular level. Using the 2 established biomarkers, estimated glomerular filtration rate (eGFR) and albuminuria will not allow allocating patients to tailored therapy. Molecular multimarker panels as sensors for the deregulation of the various disease mechanisms combined with a better understanding of how investigational as well as approved drugs interfere with these disease processes forms the basis for platform trials in DKD. In these platform trials, patients with DKD are assigned to the most suitable treatment arm based on their molecular marker profile. Close monitoring of biomarkers after treatment initiation together with assessment of renal function and “off-target” effects will allow identification of therapy responders, with nonresponders shifted to the next-best treatment arm based on their molecular profile. In this viewpoint article, we summarize evidence on the variation of DKD disease progression as well as the response to therapy and outline procedures to model disease pathophysiology supporting biomarker panel construction. Finally, the use of biomarkers in clinical trial setup is discussed. Keywords: biomarker panel, clinical trial design, diabetic kidney disease, pathophysiology, predictive markerhttp://www.sciencedirect.com/science/article/pii/S2468024918303437 |
| spellingShingle | Paul Perco Michelle Pena Hiddo J.L. Heerspink Gert Mayer Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice? Kidney International Reports |
| title | Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice? |
| title_full | Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice? |
| title_fullStr | Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice? |
| title_full_unstemmed | Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice? |
| title_short | Multimarker Panels in Diabetic Kidney Disease: The Way to Improved Clinical Trial Design and Clinical Practice? |
| title_sort | multimarker panels in diabetic kidney disease the way to improved clinical trial design and clinical practice |
| url | http://www.sciencedirect.com/science/article/pii/S2468024918303437 |
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