Predicting the outcome of chronic kidney disease by the estimated nephron number

The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

Toshiyuki Imasawa, Takashi Nakazato, Hiroo Ikehira, Hiroyuki Fujikawa, Ryo Nakajima, Takahito Ito, Yutaka Ando, Mitsuhiro Yoshimura, Masaru Nakayama, Kensei Yahata, Osamu Sasaki, Takaaki Yaomura, Ritsuko Katafuchi, Tsuyoshi Yamamura, Takehiko Kawaguchi, Motonobu Nishimura, Hiroshi Kitamura, Takashi Kenmochi, Akira Shimatsu

Research output: Contribution to journalArticle

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Abstract

Background: The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD). If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design. The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up) study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion. This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to examine whether the nephron number predicts the outcome of CKD patients. The results from this study should provide powerful new tools for nephrologists in routine clinical practice. Trial registration. UMIN-Clinical Trial Registration, UMIN000004784.

Original languageEnglish
Article number11
JournalBMC Nephrology
Volume13
Issue number1
DOIs
Publication statusPublished - 12-03-2012

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Nephrons
Chronic Renal Insufficiency
Observational Studies
Cohort Studies
Kidney
Biopsy
Japan
Referral and Consultation
Clinical Trials
Urine
Organizations
Prospective Studies
Interviews
Mortality

All Science Journal Classification (ASJC) codes

  • Nephrology

Cite this

Imasawa, Toshiyuki ; Nakazato, Takashi ; Ikehira, Hiroo ; Fujikawa, Hiroyuki ; Nakajima, Ryo ; Ito, Takahito ; Ando, Yutaka ; Yoshimura, Mitsuhiro ; Nakayama, Masaru ; Yahata, Kensei ; Sasaki, Osamu ; Yaomura, Takaaki ; Katafuchi, Ritsuko ; Yamamura, Tsuyoshi ; Kawaguchi, Takehiko ; Nishimura, Motonobu ; Kitamura, Hiroshi ; Kenmochi, Takashi ; Shimatsu, Akira. / Predicting the outcome of chronic kidney disease by the estimated nephron number : The rationale and design of PRONEP, a prospective, multicenter, observational cohort study. In: BMC Nephrology. 2012 ; Vol. 13, No. 1.
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abstract = "Background: The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD). If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design. The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up) study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50{\%} reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion. This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to examine whether the nephron number predicts the outcome of CKD patients. The results from this study should provide powerful new tools for nephrologists in routine clinical practice. Trial registration. UMIN-Clinical Trial Registration, UMIN000004784.",
author = "Toshiyuki Imasawa and Takashi Nakazato and Hiroo Ikehira and Hiroyuki Fujikawa and Ryo Nakajima and Takahito Ito and Yutaka Ando and Mitsuhiro Yoshimura and Masaru Nakayama and Kensei Yahata and Osamu Sasaki and Takaaki Yaomura and Ritsuko Katafuchi and Tsuyoshi Yamamura and Takehiko Kawaguchi and Motonobu Nishimura and Hiroshi Kitamura and Takashi Kenmochi and Akira Shimatsu",
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Imasawa, T, Nakazato, T, Ikehira, H, Fujikawa, H, Nakajima, R, Ito, T, Ando, Y, Yoshimura, M, Nakayama, M, Yahata, K, Sasaki, O, Yaomura, T, Katafuchi, R, Yamamura, T, Kawaguchi, T, Nishimura, M, Kitamura, H, Kenmochi, T & Shimatsu, A 2012, 'Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study', BMC Nephrology, vol. 13, no. 1, 11. https://doi.org/10.1186/1471-2369-13-11

Predicting the outcome of chronic kidney disease by the estimated nephron number : The rationale and design of PRONEP, a prospective, multicenter, observational cohort study. / Imasawa, Toshiyuki; Nakazato, Takashi; Ikehira, Hiroo; Fujikawa, Hiroyuki; Nakajima, Ryo; Ito, Takahito; Ando, Yutaka; Yoshimura, Mitsuhiro; Nakayama, Masaru; Yahata, Kensei; Sasaki, Osamu; Yaomura, Takaaki; Katafuchi, Ritsuko; Yamamura, Tsuyoshi; Kawaguchi, Takehiko; Nishimura, Motonobu; Kitamura, Hiroshi; Kenmochi, Takashi; Shimatsu, Akira.

In: BMC Nephrology, Vol. 13, No. 1, 11, 12.03.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Predicting the outcome of chronic kidney disease by the estimated nephron number

T2 - The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

AU - Imasawa, Toshiyuki

AU - Nakazato, Takashi

AU - Ikehira, Hiroo

AU - Fujikawa, Hiroyuki

AU - Nakajima, Ryo

AU - Ito, Takahito

AU - Ando, Yutaka

AU - Yoshimura, Mitsuhiro

AU - Nakayama, Masaru

AU - Yahata, Kensei

AU - Sasaki, Osamu

AU - Yaomura, Takaaki

AU - Katafuchi, Ritsuko

AU - Yamamura, Tsuyoshi

AU - Kawaguchi, Takehiko

AU - Nishimura, Motonobu

AU - Kitamura, Hiroshi

AU - Kenmochi, Takashi

AU - Shimatsu, Akira

PY - 2012/3/12

Y1 - 2012/3/12

N2 - Background: The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD). If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design. The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up) study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion. This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to examine whether the nephron number predicts the outcome of CKD patients. The results from this study should provide powerful new tools for nephrologists in routine clinical practice. Trial registration. UMIN-Clinical Trial Registration, UMIN000004784.

AB - Background: The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD). If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design. The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up) study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion. This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to examine whether the nephron number predicts the outcome of CKD patients. The results from this study should provide powerful new tools for nephrologists in routine clinical practice. Trial registration. UMIN-Clinical Trial Registration, UMIN000004784.

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