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Набор скоро начнётся NCT06825676

Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial

Без фазы С лечением Renal Insufficiency, Chronic Cardiovascular Diseases (CVD)

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
В протоколе указаны: CKD Patient Management Based on Guidelines.
Кому может быть актуально
Состояния в реестре: Renal Insufficiency, Chronic, Cardiovascular Diseases (CVD). 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
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Официальное название

Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial (GRAVER)

Обзор

Study Objective: To evaluate the impact of guideline-based CKD comprehensive management medical re-education for community healthcare providers on improving cardio-renal outcomes in CKD patients. Study Design: A nationwide, multicenter, prospective, cluster-randomized controlled trial. Inclusion and Exclusion Criteria: Inclusion Criteria: Chronic kidney disease (CKD) patients meeting the following criteria: eGFR \<60 mL/min/1.73 m² or UACR \>30 mg/g on two separate occasions at least 3 months apart. Exclusion Criteria: Age \<18 years. End-stage renal disease (ESRD) with eGFR \<15 mL/min/1.73 m², or patients already on regular dialysis or having received a kidney transplant. Pregnant or breastfeeding women. Patients participating in any other clinical trials. Patients who exhibit characteristics at the screening stage that suggest they are unable to complete the study. Intervention: Control Group: Routine community training and management. Intervention Group: Training for community healthcare providers on guideline-based CKD management, including lifestyle management, risk assessment and referral recommendations, risk factor control, pharmacological treatment, and the application of a CKD management checklist incorporating these components. Efficacy Evaluation Indicators: Primary Outcome: A renal composite endpoint, defined as at least a 25% decline in eGFR, progression to ESRD (dialysis, kidney transplantation, or sustained eGFR \<15 mL/min/1.73 m²), or death due to renal or cardiovascular causes. Secondary Outcomes: Cardiovascular composite endpoint: cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure. Delayed CKD progression, defined as a reduction in the annual eGFR decline rate by 0.5-1 mL/min/1.73 m² or a 30% reduction in UACR per year. Proportion of patients receiving guideline-recommended pharmacological treatment. Safety Evaluation Indicators: Acute deterioration of renal function (serum creatinine increase \>30% within 4 weeks). New-onset hyperkalemia. Symptomatic hypotension. Recurrent hypoglycemia.

Вмешательства

  • Поведенческое CKD Patient Management Based on Guidelines
    1. Lifestyle Education: smoking cessation, physical activity, healthy eating, and weight management. 2. Pharmacological Treatment: Implement targeted and guideline-based pharmacological treatment plans for patients with different comorbidities, such as the use of RAAS inhibitors (RASi), SGLT2 inhibitors, statins, and other medications. 3. Risk Factor Management: Effectively manage risk factors such as hypertension, diabetes, and dyslipidemia, and regularly reassess these factors. 4. Risk Assessm

Первичные конечные точки

  • The renal composite endpoint [Срок оценки: 2 years]
Вторичные конечные точки (3)
  • The cardiovascular composite endpoint [Срок оценки: 2 years]
  • The delay in renal function progression in participants [Срок оценки: 2 years]
  • The proportion of patients receiving guideline - based pharmacological treatment [Срок оценки: 2 years]

Критерии участия

Критерии включения

Patients with chronic kidney disease (CKD) (defined as eGFR <60 ml/min/1.73 m² or UACR >30 mg/g on two occasions at least 3 months apart).

Критерии исключения

  • Age <18 years
  • Patients with end-stage renal disease (eGFR <15 ml/min/1.73 m²) or those already receiving regular dialysis or kidney transplantation
  • Pregnant or breastfeeding women
  • Patients currently participating in any other clinical trial
  • Patients who exhibit characteristics during the screening phase that indicate an inability to complete the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06825676 · Guangdong Provincial People's

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗