Abstract
BackgroundThe 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/DesignThe 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.DiscussionThis 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 registrationUMIN-Clinical Trial Registration, UMIN000004784.
Highlights
The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD)
This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. This is the first prospective study to examine whether the nephron number predicts the outcome of CKD patients
Low birth weight (LBW) is a risk factor for the progression of kidney diseases in compliance with the Barker hypothesis [5,6,7,8,9]. It is well-known that glomerular changes of adults who were born with a low birth weight show focal segmental glomerulosclerosis [10]
Summary
Chronic kidney disease is regarded as public health problem throughout the world [4]. The purpose of this study is to examine whether the estimated nephron number can predict the outcome of CKD patients. It will be the first prospective study of this type ever to be performed. The estimating equation may consist of the kidney size measured by ultrasound, patient sex, eGFR, birth weight, present body weight, and so on This sub-cohort study will provide us with a method for determining the cortex volume in the general clinical setting. This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. This trial was approved by the Committee on Ethics in Human Research of National Hospital Organization Chiba-East National Hospital in December 2010 (No 19)
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