Clinical trial NCT06825676: Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial
Official title: Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial (GRAVER)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Insufficiency, Chronic
Cardiovascular Diseases (CVD)
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: The First Affiliated Hospital of Chongqing Medical University，China
name: The First Affiliated Hospital of Dalian Medical University
First posted: 2025-02-13
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The renal composite endpoint
timeFrame: 2 years
Secondary outcomes:
measure: The cardiovascular composite endpoint
timeFrame: 2 years
measure: The delay in renal function progression in participants
timeFrame: 2 years
measure: The proportion of patients receiving guideline - based pharmacological treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: