Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial (GRAVER)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- The renal composite endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Research Statistician
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Usual Care Group
Participants in the control group will receive the usual care protocol. Healthcare personnel at the control center only receive routine community training without additional medical education interventions. These healthcare personnel provide routine diagnosis and treatment to patients as well as subsequent follow-up.
CKD Patient Management Based on Guidelines
The intervention group will implement comprehensive management for CKD patients based on guidelines, including lifestyle education, pharmacological treatment, risk factor management, risk assessment, referral management, and the completion of the CKD patient management checklist.
干预措施: CKD Patient Management Based on Guidelines (Behavioral)
结局指标
主要结局
The renal composite endpoint
时间窗: 2 years
a decline in eGFR of at least 25%, end - stage renal disease (including dialysis, kidney transplantation, or eGFR sustained at \<15 ml/min/1.73 m²), or death from renal/cardiovascular causes
次要结局
- The cardiovascular composite endpoint(2 years)
- The delay in renal function progression in participants(2 years)
- The proportion of patients receiving guideline - based pharmacological treatment(2 years)
研究者
Jiyan Chen
professor
Guangdong Provincial People's Hospital