Chronic Kidney Disease Prevention of An-Lo District, Keelung

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
iwenwu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00644046
First received: March 20, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
End Stage Renal Disease
Death
Behavioral: multidisciplinary predialysis education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Chronic Kidney Disease Prevention of An-Lo District, Keelung.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • reduction of estimated glomerular filtration rate by 50 % [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • death [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 1500
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Chronic kidney disease patient with standardized nephrology care
Active Comparator: 2
chronic kidney disease patient with multidisciplinary predialysis care
Behavioral: multidisciplinary predialysis education
teaching of renal knowledges, dietary support and recall of period medical visits
Other Name: MPE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All CKD patients older than 18 y/o.

Exclusion Criteria:

  • Refusal to participate in the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644046

Locations
Taiwan
Division of Nephrology
Keelung, Taiwan, 204
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Iwen Wu, MD Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: iwenwu, Attending Physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00644046     History of Changes
Other Study ID Numbers: IWW-0001, CGMH-IRB-96-0408B
Study First Received: March 20, 2008
Last Updated: September 5, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Chronic Kidney Disease
Prevention
Cardiovascular disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014