Cardiovascular Diseases (CVD), Renal Insufficiency, Chronic
Conditions
Brief summary
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.
Interventions
BEHAVIORALCKD 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 Assessment: Perform risk assessments for CKD patients based on eGFR and UACR, and implement graded management according to the results. 4、Referral Management: Refer patients with eGFR \< 30 ml/min/1.73m² or severe proteinuria. 5、CKD Patient Management Checklist: Community doctors should complete the CKD patient management checklist in a standardized manner, including records of risk factors, dynamic kidney function, and follow-up plans.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
First Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Dalian Medical University
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Research Statistician
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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).
Exclusion criteria
1. Age \<18 years 2. Patients with end-stage renal disease (eGFR \<15 ml/min/1.73 m²) or those already receiving regular dialysis or kidney transplantation 3. Pregnant or breastfeeding women 4. Patients currently participating in any other clinical trial 5. Patients who exhibit characteristics during the screening phase that indicate an inability to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The renal composite endpoint | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The cardiovascular composite endpoint | 2 years | cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure |
| The delay in renal function progression in participants | 2 years | a decline in eGFR slope of 0.5-1.0 mL/min/1.73 m² per year or a reduction in uACR of 30% per year |
| The proportion of patients receiving guideline - based pharmacological treatment | 2 years | The proportion of patients receiving guideline - based pharmacological treatment |
Countries
China
Contacts
Primary ContactJiYan Chen, PHD
Outcome results
None listed