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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06825676
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-09
• Study First Submitted QC: 2025-02-09
• Last Update Submitted: 2025-02-09
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-03
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The renal composite endpoint	2 years	a decline in eGFR of at least 25%, end - stage renal disease (including dialysis, kidney transplantation, or eGFR sustained at \<15 ml/min/1.73 m²), or death from renal/cardiovascular causes

Secondary Outcome Measures

Name	Time	Method
The cardiovascular composite endpoint	2 years	cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure
The delay in renal function progression in participants	2 years	a decline in eGFR slope of 0.5-1.0 mL/min/1.73 m² per year or a reduction in uACR of 30% per year
The proportion of patients receiving guideline - based pharmacological treatment	2 years	The proportion of patients receiving guideline - based pharmacological treatment

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 GuangZhou, Guangdong, China