Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CKD Patient Management Based on Guidelines.
- Who it may be relevant to
- Registry conditions: Renal Insufficiency, Chronic, Cardiovascular Diseases (CVD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial (GRAVER)
Overview
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.
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 Assessm
Primary outcome measures
- The renal composite endpoint [Time frame: 2 years]
Secondary outcome measures (3)
- The cardiovascular composite endpoint [Time frame: 2 years]
- The delay in renal function progression in participants [Time frame: 2 years]
- The proportion of patients receiving guideline - based pharmacological treatment [Time frame: 2 years]
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
- Age <18 years
- Patients with end-stage renal disease (eGFR <15 ml/min/1.73 m²) or those already receiving regular dialysis or kidney transplantation
- Pregnant or breastfeeding women
- Patients currently participating in any other clinical trial
- Patients who exhibit characteristics during the screening phase that indicate an inability to complete the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT06825676 · Guangdong Provincial People's