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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Not yet enrolling

Conditions: Cardiovascular Diseases (CVD); Renal Insufficiency, Chronic

Treatments: Behavioral: CKD Patient Management Based on Guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT06825676

Guangdong Provincial People's

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 2 patient groups

Usual Care Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: CKD Patient Management Based on Guidelines