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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03004898
Other study ID # IWW-0006
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2013

Study information

Verified date March 2020
Source Chang Gung Memorial Hospital
Contact Tsang-Tang Hsieh, MD
Phone +886-2-27135211
Email tth3388@adm.cgmh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

CKD is a global endemic disease with increased comorbidities and mortality. The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education deep into the community remains limited. The aims of this study are:

1. Explore risk factors associated with CKD in the community

2. Establish multidisciplinary care model in the community

3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in behavioral , physiological, immune and metabolomics aspects

4. Provide bio-specimen repository for future study


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- residents of Northern Taiwan

Exclusion Criteria:

- pregnancy women, unwilling to participate

Study Design


Intervention

Behavioral:
multidisciplinary renal education
multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.

Locations

Country Name City State
Taiwan Department of Nephrology, Chang Gung Memorial Hospital Keelung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Chen SH, Tsai YF, Sun CY, Wu IW, Lee CC, Wu MS. The impact of self-management support on the progression of chronic kidney disease--a prospective randomized controlled trial. Nephrol Dial Transplant. 2011 Nov;26(11):3560-6. doi: 10.1093/ndt/gfr047. Epub 2011 Mar 17. — View Citation

Wu IW, Wang SY, Hsu KH, Lee CC, Sun CY, Tsai CJ, Wu MS. Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Nephrol Dial Transplant. 2009 Nov;24(11):3426-33. doi: 10.1093/ndt/gfp259. Epub 2009 Jun 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary eGFR < 60 mL/min change of renal function between groups through study completion, every 1 year
Primary albuminuria/creatinine ratio >=30 change of proteinuria between groups through study completion, every 1 year
Primary proteinuria/creatine ratio >=150 change of proteinuria between groups through study completion, every 1 year
Secondary SF-36 change of score between groups through study completion, every 1 year