Contribution of Predictive and Prognostic Biomarkers to Clinical Research on Chronic Kidney Disease

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Abstract

Chronic kidney disease (CKD), defined as the presence of albuminuria and/or reduction in estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m ², is considered a growing public health problem, with its prevalence and incidence having almost doubled in the past three decades. The implementation of novel biomarkers in clinical practice is crucial, since it could allow earlier diagnosis and lead to an improvement in CKD outcomes. Nevertheless, a clear guidance on how to develop biomarkers in the setting of CKD is not yet available. The aim of this review is to report the framework for implementing biomarkers in observational and intervention studies. Biomarkers are classified as either prognostic or predictive; the first type is used to identify the likelihood of a patient to develop an endpoint regardless of treatment, whereas the second type is used to determine whether the patient is likely to benefit from a specific treatment. Many single assays and complex biomarkers were shown to improve the prediction of cardiovascular and kidney outcomes in CKD patients on top of the traditional risk factors. Biomarkers were also shown to improve clinical trial designs. Understanding the correct ways to validate and implement novel biomarkers in CKD will help to mitigate the global burden of CKD and to improve the individual prognosis of these high-risk patients.

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Cardiorenal Syndrome: Classification, Pathophysiology, Diagnosis, and Treatment Strategies: A Scientific Statement From the American Heart Association

Janani Rangaswami, Vivek Bhalla, John Blair … (2019)

Cardiorenal syndrome encompasses a spectrum of disorders involving both the heart and kidneys in which acute or chronic dysfunction in 1 organ may induce acute or chronic dysfunction in the other organ. It represents the confluence of heart-kidney interactions across several interfaces. These include the hemodynamic cross-talk between the failing heart and the response of the kidneys and vice versa, as well as alterations in neurohormonal markers and inflammatory molecular signatures characteristic of its clinical phenotypes. The mission of this scientific statement is to describe the epidemiology and pathogenesis of cardiorenal syndrome in the context of the continuously evolving nature of its clinicopathological description over the past decade. It also describes diagnostic and therapeutic strategies applicable to cardiorenal syndrome, summarizes cardiac-kidney interactions in special populations such as patients with diabetes mellitus and kidney transplant recipients, and emphasizes the role of palliative care in patients with cardiorenal syndrome. Finally, it outlines the need for a cardiorenal education track that will guide future cardiorenal trials and integrate the clinical and research needs of this important field in the future.

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Analysis of the Global Burden of Disease study highlights the global, regional, and national trends of chronic kidney disease epidemiology from 1990 to 2016

Cheng-You Tsai, Tasheia Floyd, Geetha Maddukuri … (2018)

The last quarter century witnessed significant population growth, aging, and major changes in epidemiologic trends, which may have shaped the state of chronic kidney disease (CKD) epidemiology. Here, we used the Global Burden of Disease study data and methodologies to describe the change in burden of CKD from 1990 to 2016 involving incidence, prevalence, death, and disability-adjusted-life-years (DALYs). Globally, the incidence of CKD increased by 89% to 21,328,972 (uncertainty interval 19,100,079- 23,599,380), prevalence increased by 87% to 275,929,799 (uncertainty interval 252,442,316-300,414,224), death due to CKD increased by 98% to 1,186,561 (uncertainty interval 1,150,743-1,236,564), and DALYs increased by 62% to 35,032,384 (uncertainty interval 32,622,073-37,954,350). Measures of burden varied substantially by level of development and geography. Decomposition analyses showed that the increase in CKD DALYs was driven by population growth and aging. Globally and in most Global Burden of Disease study regions, age-standardized DALY rates decreased, except in High-income North America, Central Latin America, Oceania, Southern Sub-Saharan Africa, and Central Asia, where the increased burden of CKD due to diabetes and to a lesser extent CKD due to hypertension and other causes outpaced burden expected by demographic expansion. More of the CKD burden (63%) was in low and lower-middle-income countries. There was an inverse relationship between age-standardized CKD DALY rate and health care access and quality of care. Frontier analyses showed significant opportunities for improvement at all levels of the development spectrum. Thus, the global toll of CKD is significant, rising, and unevenly distributed; it is primarily driven by demographic expansion and in some regions a significant tide of diabetes. Opportunities exist to reduce CKD burden at all levels of development.

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Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease.

Tamara Isakova, Huiliang Xie, Wei Yang … (2011)

A high level of the phosphate-regulating hormone fibroblast growth factor 23 (FGF-23) is associated with mortality in patients with end-stage renal disease, but little is known about its relationship with adverse outcomes in the much larger population of patients with earlier stages of chronic kidney disease. To evaluate FGF-23 as a risk factor for adverse outcomes in patients with chronic kidney disease. A prospective study of 3879 participants with chronic kidney disease stages 2 through 4 who enrolled in the Chronic Renal Insufficiency Cohort between June 2003 and September 2008. All-cause mortality and end-stage renal disease. At study enrollment, the mean (SD) estimated glomerular filtration rate (GFR) was 42.8 (13.5) mL/min/1.73 m(2), and the median FGF-23 level was 145.5 RU/mL (interquartile range [IQR], 96-239 reference unit [RU]/mL). During a median follow-up of 3.5 years (IQR, 2.5-4.4 years), 266 participants died (20.3/1000 person-years) and 410 reached end-stage renal disease (33.0/1000 person-years). In adjusted analyses, higher levels of FGF-23 were independently associated with a greater risk of death (hazard ratio [HR], per SD of natural log-transformed FGF-23, 1.5; 95% confidence interval [CI], 1.3-1.7). Mortality risk increased by quartile of FGF-23: the HR was 1.3 (95% CI, 0.8-2.2) for the second quartile, 2.0 (95% CI, 1.2-3.3) for the third quartile, and 3.0 (95% CI, 1.8-5.1) for the fourth quartile. Elevated fibroblast growth factor 23 was independently associated with significantly higher risk of end-stage renal disease among participants with an estimated GFR between 30 and 44 mL/min/1.73 m(2) (HR, 1.3 per SD of FGF-23 natural log-transformed FGF-23; 95% CI, 1.04-1.6) and 45 mL/min/1.73 m(2) or higher (HR, 1.7; 95% CI, 1.1-2.4), but not less than 30 mL/min/1.73 m(2). Elevated FGF-23 is an independent risk factor for end-stage renal disease in patients with relatively preserved kidney function and for mortality across the spectrum of chronic kidney disease.

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Journal

Journal ID (nlm-ta): Int J Mol Sci

Journal ID (iso-abbrev): Int J Mol Sci

Journal ID (publisher-id): ijms

Title: International Journal of Molecular Sciences

Publisher: MDPI

ISSN (Electronic): 1422-0067

Publication date (Electronic): 14 August 2020

Publication date Collection: August 2020

Volume: 21

Issue: 16

Electronic Location Identifier: 5846

Affiliations

[1 ]Renal Unit, Department of Health Sciences, “Magna Graecia” University of Catanzaro, I-88100 Catanzaro, Italy; ida_88@ 123456libero.it (I.G.); ashourmichael@ 123456yahoo.com (A.M.)

[2 ]Department of Health Sciences, “Magna Graecia” University of Catanzaro, I-88100 Catanzaro, Italy; srotundo91@ 123456gmail.com (S.R.); foti@ 123456unicz.it (D.F.)

[3 ]Medical Statistics Unit, University of Campania Luigi Vanvitelli, I-80138 Naples, Italy; paolo.chiodini@ 123456unicampania.it

[4 ]Clinical Biochemistry Unit, Azienda Ospedaliera Universitaria Mater Domini Hospital, I-88100 Catanzaro, Italy; e.angotti@ 123456materdominiaou.it

[5 ]Renal Unit, University of Campania “Luigi Vanvitelli”, I-80138 Naples, Italy; dott.silvioborrelli@ 123456gmail.com

[6 ]Interuniversity Center of Phlebolymphology (CIFL), “Magna Graecia” University of Catanzaro, I-88100 Catanzaro, Italy; rserra@ 123456unicz.it

[7 ]Pharmacology Unit, Department of Health Sciences, School of Medicine, “Magna Graecia” University of Catanzaro, I-88100 Catanzaro, Italy; desarro@ 123456unicz.it

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[* ]Correspondence: michiprov@ 123456hotmail.it (M.P.); andreucci@ 123456unicz.it (M.A.); Tel.: +39-3407544146 (M.P.); +39-3396814750 (M.A.)

Author information

Michele Provenzano https://orcid.org/0000-0002-2168-702X

Silvio Borrelli https://orcid.org/0000-0002-4414-4597

Raffaele Serra https://orcid.org/0000-0003-4477-7412

Daniela Foti https://orcid.org/0000-0002-9536-5736

Article

Publisher ID: ijms-21-05846

DOI: 10.3390/ijms21165846

PMC ID: 7461617

PubMed ID: 32823966

SO-VID: 803587f7-c72d-4d6d-b907-df7955a89240

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Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

Contribution of Predictive and Prognostic Biomarkers to Clinical Research on Chronic Kidney Disease

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Most cited references 101

Cardiorenal Syndrome: Classification, Pathophysiology, Diagnosis, and Treatment Strategies: A Scientific Statement From the American Heart Association

Analysis of the Global Burden of Disease study highlights the global, regional, and national trends of chronic kidney disease epidemiology from 1990 to 2016

Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease.

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