Chronic Kidney Disease Prevention of An-Lo District, Keelung

Phase 4

Completed

• Conditions: Chronic Kidney Disease; End Stage Renal Disease; Death
• Interventions: Behavioral: multidisciplinary predialysis education

• Registration Number: NCT00644046
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan (1, 2). More than 45,000 patients are under renal replacement therapy in the year 2004 (2). The disease had not only caused a significant impact in personal life, but also a great burden on social security and government-run health insurance. However, despite this high prevalence, the awareness of chronic kidney disease (CKD) in general population remains low (3, 4). The patients always come out too late for the intervention to slow down the progression of renal failure. Furthermore, most of them are not well prepared for the renal replacement therapy. The facts result in high mortality and morbidity in this specific population (5). It is mandatory to screen out and treat these patients early enough. However, these patients are deep into the community as the asymptomatic nature of CKD.

The major purpose of the study is to screen the community for the early CKD and provide the appropriate intervention at time. The study will collect the characteristic demographic epidemiological data and find out risk factors for CKD of this geographic area, provide multidisciplinary education of CKD and establish timely referral for appropriate nephrologist care for treatment and monitoring of complications.

Detailed Description

The project will be last for 3 years. We will start to screen the patients within the community to identify the CKD population. This population will randomized into two group (one group with standard nephrologist care and another group with standard nephrologist care plus multidisciplinary CKD education) to evaluate the effectiveness of CKD education on the progression of renal function. The primary end-point will be the doubling tine estimated GFR, development of end-stage renal disease and all cause mortality. The non-CKD group of community will also follow up for urine and blood test for renal function, to determine the incidence and risk factors of new-onset renal disease. The accomplishment of this study will retard renal progression, improve community health and establish a model in preventing the chronic kidney disease.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• All CKD patients older than 18 y/o.

Exclusion Criteria

• Refusal to participate in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	multidisciplinary predialysis education	chronic kidney disease patient with multidisciplinary predialysis care

Primary Outcome Measures

Name	Time	Method
reduction of estimated glomerular filtration rate by 50 %	1 year

Secondary Outcome Measures

Name	Time	Method
death	1 year

Trial Locations

Locations (1)

Division of Nephrology; 🇨🇳 Keelung, Taiwan