Urinary type IV collagen excretion is involved in the decline in estimated glomerular filtration rate in the Japanese general population without diabetes: A 5-year observational study

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Abstract

Urinary type IV collagen (U-Col4) and albumin excretion is evaluated to monitor the development of diabetic kidney disease. However, U-Col4 excretion in the general population without diabetes has not yet been fully elucidated. In this study, 1067 participants without diabetes and with urinary albumin-creatinine ratio <300 mg/gCr (normo- or microalbuminuria) who underwent an annual health examination in 2004 were enrolled and observed for 5 years. They were divided according to the amount of U-Col4 or urinary albumin excreted. The decline in estimated glomerular filtration rate (eGFR) was calculated. In participants with eGFR ≥80 mL/min, abnormal U-Col4 excretion was indicated as a significant independent risk factor for 10% eGFR change per year, which is one of the prognostic factors for the development of end-stage kidney disease. Moreover, in contrast to urinary albumin excretion, U-Col4 excretion was not related to age or kidney function, suggesting that some individuals with abnormal U-Col4 excretion can have an independent hidden risk for the development of kidney dysfunction. In conclusion, it is important to measure U-Col4 excretion in the general population without diabetes to determine changes in renal features in every individual and help detect future complications such as diabetic kidney disease. If U-Col4 excretion is abnormal, kidney manifestation should be carefully followed up, even if the kidney function and urinalysis findings are normal.

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Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality.

Josef Coresh, Tanvir Turin, Kunihiro Matsushita … (2014)

The established chronic kidney disease (CKD) progression end point of end-stage renal disease (ESRD) or a doubling of serum creatinine concentration (corresponding to a change in estimated glomerular filtration rate [GFR] of −57% or greater) is a late event. To characterize the association of decline in estimated GFR with subsequent progression to ESRD with implications for using lesser declines in estimated GFR as potential alternative end points for CKD progression. Because most people with CKD die before reaching ESRD, mortality risk also was investigated. Individual meta-analysis of 1.7 million participants with 12,344 ESRD events and 223,944 deaths from 35 cohorts in the CKD Prognosis Consortium with a repeated measure of serum creatinine concentration over 1 to 3 years and outcome data. Transfer of individual participant data or standardized analysis of outputs for random-effects meta-analysis conducted between July 2012 and September 2013, with baseline estimated GFR values collected from 1975 through 2012. End-stage renal disease (initiation of dialysis or transplantation) or all-cause mortality risk related to percentage change in estimated GFR over 2 years, adjusted for potential confounders and first estimated GFR. The adjusted hazard ratios (HRs) of ESRD and mortality were higher with larger estimated GFR decline. Among participants with baseline estimated GFR of less than 60 mL/min/1.73 m2, the adjusted HRs for ESRD were 32.1 (95% CI, 22.3-46.3) for changes of −57% in estimated GFR and 5.4 (95% CI, 4.5-6.4) for changes of −30%. However, changes of −30% or greater (6.9% [95% CI, 6.4%-7.4%] of the entire consortium) were more common than changes of −57% (0.79% [95% CI, 0.52%-1.06%]). This association was strong and consistent across the length of the baseline period (1 to 3 years), baseline estimated GFR, age, diabetes status, or albuminuria. Average adjusted 10-year risk of ESRD (in patients with a baseline estimated GFR of 35 mL/min/1.73 m2) was 99% (95% CI, 95%-100%) for estimated GFR change of −57%, was 83% (95% CI, 71%-93%) for estimated GFR change of −40%, and was 64% (95% CI, 52%-77%) for estimated GFR change of −30% vs 18% (95% CI, 15%-22%) for estimated GFR change of 0%. Corresponding mortality risks were 77% (95% CI, 71%-82%), 60% (95% CI, 56%-63%), and 50% (95% CI, 47%-52%) vs 32% (95% CI, 31%-33%), showing a similar but weaker pattern. Declines in estimated GFR smaller than a doubling of serum creatinine concentration occurred more commonly and were strongly and consistently associated with the risk of ESRD and mortality, supporting consideration of lesser declines in estimated GFR (such as a 30% reduction over 2 years) as an alternative end point for CKD progression.

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GFR decline as an end point for clinical trials in CKD: a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.

Andrew Levey, Lesley A. Inker, Kunihiro Matsushita … (2014)

The US Food and Drug Administration currently accepts halving of glomerular filtration rate (GFR), assessed as doubling of serum creatinine level, as a surrogate end point for the development of kidney failure in clinical trials of kidney disease progression. A doubling of serum creatinine level generally is a late event in chronic kidney disease (CKD); thus, there is great interest in considering alternative end points for clinical trials to shorten their duration, reduce sample size, and extend their conduct to patients with earlier stages of CKD. However, the relationship between lesser declines in GFR and the subsequent development of kidney failure has not been well characterized. The National Kidney Foundation and Food and Drug Administration sponsored a scientific workshop to critically examine available data to determine whether alternative GFR-based end points have sufficiently strong relationships with important clinical outcomes of CKD to be used in clinical trials. Based on a series of meta-analyses of cohorts and clinical trials and simulations of trial designs and analytic methods, the workshop concluded that a confirmed decline in estimated GFR of 30% over 2 to 3 years may be an acceptable surrogate end point in some circumstances, but the pattern of treatment effects on GFR must be examined, specifically acute effects on estimated GFR. An estimated GFR decline of 40% may be more broadly acceptable than a 30% decline across a wider range of baseline GFRs and patterns of treatment effects on GFR. However, there are other circumstances in which these end points could lead to a reduction in statistical power or erroneous conclusions regarding benefits or harms of interventions. We encourage careful consideration of these alternative end points in the design of future clinical trials.

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International clinical harmonization of glycated hemoglobin in Japan: From Japan Diabetes Society to National Glycohemoglobin Standardization Program values

Atsunori Kashiwagi, Masato Kasuga, Eiichi Araki … (2012)

In 1999, the Japan Diabetes Society (JDS) launched the previous version of the diagnostic criteria of diabetes mellitus, in which JDS took initiative in adopting glycated hemoglobin (HbA1c) as an adjunct to the diagnosis of diabetes. In contrast, in 2009 the International Expert Committee composed of the members of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) manifested the recommendation regarding the use of HbA1c in diagnosing diabetes mellitus as an alternative to glucose measurements based on the updated evidence showing that HbA1c has several advantages as a marker of chronic hyperglycemia 2–4 . The JDS extensively evaluated the usefulness and feasibility of more extended use of HbA1c in the diagnosis of diabetes based on Japanese epidemiological data, and then the ‘Report of the Committee on the Classification and Diagnostic Criteria of Diabetes Mellitus’ was published in the Journal of Diabetes Investigation 5 and Diabetology International 6 . The new diagnostic criterion in Japan came into effect on 1 July 2010. According to the new version of the criteria, HbA1c (JDS) ≥6.1% is now considered to indicate a diabetic type, but the previous diagnosis criteria of high plasma glucose (PG) levels to diagnose diabetes mellitus also need to be confirmed. Those are as follows: (i) FPG ≥126 mg/dL (7.0 mmol/L); (ii) 2‐h PG ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; or (iii) casual PG ≥200 mg/dL (11.1 mmol/L). If both PG criteria and HbA1c in patients have met the diabetic type, those patients are immediately diagnosed to have diabetes mellitus 5,6 . In the report, the HbA1c measurements in Japan are well calibrated with Japanese‐Clinical‐Laboratory‐Use Certified Reference Material (JCCRM). The certified values are determined by a high‐resolution type ion‐exchange high performance liquid chromatography (HPLC) (KO 500 method) and certified using the designated comparison method (DCM) of the Japan Society of Clinical Chemistry (JSCC) and the JDS. After incorporating a proportional bias correction to the value anchored to the peptide mapping method of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the DCM actually measures β‐N‐mono‐deoxyfructosyl hemoglobin and has an intercept approximately equal to zero against the peptide mapping method of IFCC in measuring fresh raw human blood samples. Furthermore, standardization of HbA1c in Japan was initiated in 1993, and the serial reference materials from JDS Lot 1 to JDS Lot 4 are well certified using the DCM until now. In the new diagnosis criteria 5,6 , the new cut‐point of HbA1c (JDS) for diagnosis of diabetes mellitus is 6.1%, which is equivalent to the internationally‐used HbA1c (National Glycohemoglobin Standardization Program [NGSP]) 6.5%, as HbA1c (NGSP)(%) is reported to be equivalent to 1.019 × HbA1c (JDS)% + 0.3%, which is reasonably estimated by the equation of HbA1c (JDS)% + 0.4%, as the difference between the two equations is within error of HbA1c measurements (2∼3%). However, on 1 October 2011, the Reference Material Institute for Clinical Chemistry Standards (ReCCS, Kanagawa, Japan) was certified as an Asian Secondary Reference Laboratory (ASRL) using the KO 500 method and the reference materials JCCRM411‐2 (JDS Lot 4) after successful completion of NGSP network laboratory certification. Therefore, the HbA1c unit is now traceable to the Diabetes Control and Complications Trial (DCCT) reference method. The comparison was carried out with the Central Primary Reference Laboratory (CPRL) in the University of Missouri School of Medicine. The conversion equation from HbA1c (JDS) to HbA1c (NGSP) units is officially certified as follows: NGSP (%) = 1.02 × JDS (%) + 0.25%; conversely, JDS (%) = 0.980 × NGSP (%) – 0.245%. Based on this equation, in the range of JDS values ≤4.9%, NGSP (%) = JDS (%) + 0.3%; in the range of JDS 5.0∼9.9%, NGSP (%) = JDS (%) + 0.4%; and in the range of JDS 10∼14.9%, NGSP (%) = JDS (%) + 0.5%. These results show that the previous equation of NGSP (%) = JDS (%) + 0.4% is also confirmed in the present equation, considering a 2∼3% error of HbA1c measurements. The council meeting of the JDS finally decided to use HbA1c (NGSP) values in clinical practice from 1 April 2012, although HbA1c (JDS) values will be included until people become familiar with the new expression. Finally, it is also important to emphasize that the new HbA1c (NGSP) values can be directly measured and printed out from 1 April 2012. However, both new diagnostic reference values and target values of glycemic control have been adjusted to those equivalent values of HbA1c (JDS), as shown in the Table 1. Table 1 Differences in glycated hemoglobin values between Japan Diabetes Society and National Glycohemoglobin Standardization Program for assessments of diagnosis and treatment of diabetes mellitus (a) Diagnostic reference values of HbA1c (NGSP) and HbA1c (JDS) Diagnostic reference values HbA1c (NGSP) HbA1c (JDS) Standard range (%) 4.6–6.2 4.3–5.8 Diabetes range (%) ≥6.5 ≥6.1 Possible diabetes range (%) 6.0–6.4 5.6–6.0 High risk range for diabetes (%) 5.6–5.9 5.2–5.5 (b) Assessments of the glycemic control using HbA1c Assessment of control state HbA1c (NGSP) HbA1c (JDS) Excellent (%) <6.2 <5.8 Good (%) 6.2–6.8 5.8–6.4 Fair Inadequate (%) 6.9–7.3 6.5–6.9 Not good (%) 7.4–8.3 7.0–7.9 Poor (%) ≥8.4 ≥8.0 HbA1c, glycated hemoglobin; JDS, Japan Diabetes Society; NGSP, National Glycohemoglobin Standardization Program.

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Author and article information

Contributors

Fumi Kishi: Role: Writing – original draft

Kojiro Nagai:

ORCID: http://orcid.org/0000-0002-8348-2855

Role: Writing – original draft

Norimichi Takamatsu: Role: Formal analysis

Tatsuya Tominaga: Role: Data curation

Masanori Tamaki: Role: Data curation

Eriko Shibata: Role: Data curation

Taichi Murakami: Role: Data curation

Seiji Kishi: Role: Data curation

Hideharu Abe: Role: Data curation

Yasuhiko Koezuka: Role: Conceptualization

Naoto Minagawa: Role: Formal analysis

Go Ichien: Role: Conceptualization

Toshio Doi: Role: Writing – review & editing

Tatsuo Shimosawa: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 6 April 2018

Publication date Collection: 2018

Volume: 13

Issue: 4

Electronic Location Identifier: e0195523

Affiliations

[1 ] Department of Nephrology, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan

[2 ] Department of Kidney Disease (Dialysis & Transplantation), Kawashima Hospital, Tokushima, Japan

[3 ] Department of Chronomedicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan

[4 ] HuBit Genomix Inc., Tokyo, Japan

The University of Tokyo, JAPAN

Author notes

Competing Interests: The authors declare that co-author Hideharu Abe is a PLOS ONE Editorial board member. The authors also declare that co-authors Naoto Minagawa, Yasuhiko Koezuka and Go Ichien belong to HuBit Genomix Inc. and are employed by a commercial company (HuBit Genomix Inc.). This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

* E-mail: knagai@ 123456tokushima-u.ac.jp

Author information

Kojiro Nagai http://orcid.org/0000-0002-8348-2855

Article

Publisher ID: PONE-D-17-40578

DOI: 10.1371/journal.pone.0195523

PMC ID: 5889187

PubMed ID: 29624611

SO-VID: fb4e617d-797e-4afa-9091-7397ab09294e

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This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 16 November 2017

Date accepted : 23 March 2018

Page count

Figures: 3, Tables: 5, Pages: 14

Funding

The authors received no specific funding for this work. HuBit Genomix Inc. provided support in the form of salaries for authors YK, NM and GI but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the 'author contributions' section.

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Urinary type IV collagen excretion is involved in the decline in estimated glomerular filtration rate in the Japanese general population without diabetes: A 5-year observational study

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PLOS Climate

Most cited references 29

Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality.

GFR decline as an end point for clinical trials in CKD: a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.

International clinical harmonization of glycated hemoglobin in Japan: From Japan Diabetes Society to National Glycohemoglobin Standardization Program values

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