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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | No Intervention | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD Patient Management Based on Guidelines | Behavioral |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| The renal composite endpoint | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The cardiovascular composite endpoint | cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure | 2 years |
| The delay in renal function progression in participants |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JiYan Chen, PHD | Contact | 86-020-83827812-10528 | Chen-jiyan@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
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Research Statistician
|
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
| 2 years |
| The proportion of patients receiving guideline - based pharmacological treatment | The proportion of patients receiving guideline - based pharmacological treatment | 2 years |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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