Идёт набор NCT05188885

A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases

— Наблюдательное Chronic Kidney Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Chronic Kidney Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Chronic kidney disease (CKD) refers to a variety of different diseases characterized by impairment of kidney structure and/or renal function. The prevalence of CKD in China is as high as 10.8%. With a population of more than 150 million, China has the largest number of CKD patients all over the world. People with CKD would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-CKD population. It has created a heavy burden on people's health and national economy. There is an urgent need to establish an effective system for CKD prevention and control in China. Evidences from large sample cohort and real world based research are still rare. This study will provide good experience for reducing the occurrence and development of CKD.

Подробное описание

This study is designed as an investigator-initiated, multi-center, prospective and observational real world study based on mainland Chinese population. The investigators aimed to investigate the occurrence, development, treatment, prognosis state and related risk factors of CKD in China.

This study based on the standardized data network, which provides efficient data collection, integration and analysis for researchers and clinicians in multi-centers.

The sample size of this study was estimated by statisticians, epidemiologists and clinicians. Real-world studies adopted an open standard for inclusion and exclusion, larger sample size could cover a wider group of patients and take the possibility of loss of follow-up into account. Subgroup analysis can be performed in a heterogeneous population and expand the significance of the study.

Первичные конечные точки

The occurrence of chronic kidney diseases in non-CKD participants [Срок оценки: up to 5 years]
The progression of chronic kidney diseases in CKD participants [Срок оценки: up to 5 years]

Вторичные конечные точки (8)

Progression in albuminuria [Срок оценки: up to 5 years]
New onset of albuminuria [Срок оценки: up to 5 years]
New onset of macroalbuminuria [Срок оценки: up to 5 years]
Composite endpoints of progression of chronic kidney disease and progression of albuminuria [Срок оценки: up to 5 years]
Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death. [Срок оценки: up to 5 years]
Change of estimated eGFR [Срок оценки: up to 5 years]
change of uACR [Срок оценки: up to 5 years]
Rapid decrease of renal function [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition;
Non-CKD patients with hypertension, diabetes, hyperlipidemia, hyperuricemia, eGFR (CKD-EPI formula) of 60-89 ml/min/1.73m\^2 and other risk factors for CKD;
Healthy population.
Signed the informed consent voluntarily.