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

NCT ID: NCT06825676

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-03-31

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.

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases (CVD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

CKD Patient Management Based on Guidelines

Intervention Type: BEHAVIORAL

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.

Interventions

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 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiyan Chen

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Countries

China

Central Contacts

JiYan Chen, PHD

Role: CONTACT

Chen-jiyan@163.com

86-020-83827812-10528

Facility Contacts

JiYan Chen, PHD

Role: primary

Chen-jiyan@163.com

86-020-83827812-10528

Other Identifiers

Guangdong Provincial People's

Identifier Type: -

Identifier Source: org_study_id