Ministry of Health, Labour and Welfare Prevention of Kidney Disease Progression Action Plan

Transcription

1 9 th IKEAJ-CKD International Symposium Ministry of Health, Labour and Welfare Prevention of Kidney Disease Progression Action Plan Division of Nephrology, Hypertension and Endocrinology, Department of Medicine, Nihon University School of Medicine Kazuyoshi Okada

2 Background A large-scale outcome study was conducted over five years from 2007 until 2011 by the strategic research team for the Prevention of Kidney Disease Progression, part of the Health and Labour Sciences Research group, in an attempt to confront this national problem. Following a strict study protocol, this led to the creation of a Lifestyle and Diet handbook aimed at providing guidance to patients with chronic kidney disease (CKD). In order to optimize the handbook by taking regional characteristics into consideration, allowing immediate implementation in each designated region, modifications were required. Accordingly, the Ministry of Health, Labour and Welfare conducted an open recruitment for the implementation of the Prevention of Kidney Disease Progression Action Plan. The IKEAJ was selected to implement the project in the Hokkaido, Tohoku and Kanto regions.

3 Study Objectives To make necessary modifications to the Lifestyle and Diet handbook prepared by the strategic research team for the Prevention of Kidney Disease Progression, thereby creating an optimum handbook which takes regional characteristics into consideration, allowing immediate implementation in each designated region. To use the handbook to provide individual guidance on lifestyle and diet to patients with CKD, and, subsequently, evaluate the effectiveness of the methods outlined in the handbook.

4 Study Design Open-label Study Subjects Inclusion criteria 1. Aged 20 years or above. 2. CKD stage 1 to Subjects who take blood pressure measurements at home (morning and before bed) using an upper arm monitor. 4. Willing to consent to undergo tests (urine and blood), receive guidance (lifestyle and diet) and fill out medical questionnaires every 3 months. 5. Willing to provide written consent. Exclusion criteria 1. Those who fail to strictly comply with the guidance given.

5 Procedure On admission, all subjects are required to complete the medical questionnaire and sign the informed consent form. Height, weight, waist circumference and blood pressure measurements will then be recorded, average home blood pressure values calculated and the official section of the medical questionnaire completed. The informed consent form, medical questionnaire and list of medications will then be submitted to IKEAJ. Once notified of the registration number by IKEAJ, the study will be started and blood tests and urinalysis performed. A 3-month observation period will be established. Three months after the initial examination (urine and blood), a second examination will be performed and guidance given on lifestyle and diet. Further examinations and additional guidance on lifestyle and diet will subsequently be performed at 3-month intervals thereafter. Medical questionnaires completed at the second and subsequent examinations will be submitted to IKEAJ.

6 Testing program All laboratory tests were performed with samples collected during the medical examination and sent on the same day to a central laboratory vendor (SRL, Inc., Tokyo, Japan) Measurement of blood pressure, height, weight and waist circumference Urine protein (qualitative), urinary glucose (qualitative), urinary occult blood reaction, urinary albumin excretion rate (quantitative), urinary protein (quantitative), urinary creatinine, urinary Na, urinary K Hemoglobin, Fe, TIBC, ferritin, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, HbA1c, albumin, K, urea nitrogen, creatinine, egfr (Cr; ml/min/1.73 m 2 ), uric acid, cystatin C, egfr (Cys-C; ml/min/1.73 m 2 )

7 Lifestyle guidance Lifestyle guidance will be provided by physicians or dietitians, who will also, on a regular basis, confirm that the subjects are complying with the guidance given, before continuing with instruction Dietary guidance Dietary guidance will be provided by dietitians of the same person in principle who will also, on a regular basis, confirm that the subjects are complying with the guidance given, before continuing with instruction

8 Documents Program for the Prevention of Kidney Disease Progression First Examination Follow-up Examination Food record chart Diet and Exercise Check Sheet

9 Program for the Prevention of Kidney Disease Progression (First Examination)

10 Program for the Prevention of Kidney Disease Progression (Follow-up Examination)

11 Food record chart

12 Diet and Exercise Check Sheet

13 Study Period From November 29, 2012 until completion of the Prevention of Kidney Disease Progression Action Plan. Registration Period From November 29, 2012 to December 31, 2013 Target Number of Subjects 150 subjects

14 Endpoints Primary Endpoints 1. Changes in egfr (Cr) 2. Changes in egfr (Cystatin C) 3. Changes in urinary albumin excretion 4. Changes in quantitative urine protein Secondary Endpoints 1. Changes in abdominal circumference and body mass index 2. Changes in average home blood pressure values (morning, before bed) 3. Changes in the central measurement test values (BS, HbA1c, LDL-C, HDL-C, TG, non HDL-CUA, Hb, Alb, Fe, TIBC, ferritin, Cr, cystatin C, urinary Na) 4. Evaluation of changes in parameters due to compliance with lifestyle guidance. 5. Evaluation of changes in parameters due to compliance with dietary guidance.

15 Follow-up observation period 3 months Study period number of registration number of dropout number of the first examination number of the second examination number of the third examination number of the forth examination