Clinical trial NCT04300387: Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care
Official title: Biomarker and Multidisciplinary Predialysis Education in Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: risk factors
omics
multidisciplinary care
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-03-09
Enrollment: 8000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patient receiving dialysis or transplantation
* Unwilling to participate

Primary outcomes:
measure: percentage (%)
timeFrame: through study completion, every 1 year
measure: difference of US dollars
timeFrame: through study completion, every 1 year
Secondary outcomes:
measure: fold changes of proteins
timeFrame: through study completion, every 1 year
measure: fold changes of microRNA
timeFrame: through study completion, every 1 year
Other outcomes:
measure: change of taxonomic units abundance of specific microbiota
timeFrame: through study completion, every 1 year
measure: changes of metabolites
timeFrame: through study completion, every 1 year
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: I-Wen Wu
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.