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

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)

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• China

Study Locations