Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care

Chronic Kidney Disease Clinical Trial

Official title:

Biomarker and Multidisciplinary Predialysis Education in Chronic Kidney Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300387
• Other study ID #: IWW-0005
• Status: Recruiting
• Phase: N/A
• Start date: March 2011
• Est. completion date: December 2024

Study information

• Verified date: March 2020
• Source: Chang Gung Memorial Hospital
• Contact: Tsang-Tang Hsieh
• Phone: +886-2-27135211
• Email: tth3388[@]adm.cgmh.org.tw
• Is FDA regulated: No
• 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. Early diagnosis of disease and proper management remain challenging. The aims of this study are:

1. Explore risk factors associated with CKD

2. Establish multidisciplinary care model for CKD patients

3. Development cost-effective clinical care pathway for CKD

4. Provide bio-specimen repository for future study

Description:

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. Early diagnosis of disease and proper management remain challenging. The aims of this study are:

1. Explore risk factors associated with CKD: demographic, social and genetics factors

2. Establish multidisciplinary care model for CKD patients

3. Development cost-effective clinical care pathway for CKD

4. Provide bio-specimen repository for future study: serum, PBMC, urine and stool

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects visiting outpatient clinics of nephrology of Chang Gung Memorial Hospital

Exclusion Criteria:

• Patient receiving dialysis or transplantation

• Unwilling to participate

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Keelung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

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 2 — 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change of taxonomic units abundance of specific microbiota	change of levels between groups	through study completion, every 1 year
Other	changes of metabolites	change of levels between groups	through study completion, every 1 year
Primary	percentage (%)	percentage of patients with new CKD, starting dialysis treatments, cardiovascular event or mortality	through study completion, every 1 year
Primary	difference of US dollars	differences of US dollars of medical care (out patients and inpatients service fees) between groups	through study completion, every 1 year
Secondary	fold changes of proteins	change of levels between groups	through study completion, every 1 year
Secondary	fold changes of microRNA	change of levels between groups	through study completion, every 1 year