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Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care

Primary Purpose

Chronic Kidney Disease

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

multidisciplinary care

About this trial

This is an interventional diagnostic trial for Chronic Kidney Disease focused on measuring risk factors, omics, multidisciplinary care

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects visiting outpatient clinics of nephrology of Chang Gung Memorial Hospital

Exclusion Criteria:

Patient receiving dialysis or transplantation
Unwilling to participate

Sites / Locations

Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

customary care

multidisciplinary care

Arm Description

customary care for CKD

multidisciplinary team care for CKD

Outcomes

Primary Outcome Measures

percentage (%)

percentage of patients with new CKD, starting dialysis treatments, cardiovascular event or mortality

difference of US dollars

differences of US dollars of medical care (out patients and inpatients service fees) between groups

Secondary Outcome Measures

fold changes of proteins

change of levels between groups

fold changes of microRNA

change of levels between groups

Full Information

NCT ID

NCT04300387

First Posted

September 30, 2016

Last Updated

March 6, 2020

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Science and Technology, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT04300387

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Recruiting

Study Start Date

March 2011 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Science and Technology, Taiwan

4. Oversight

5. Study Description

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: Explore risk factors associated with CKD Establish multidisciplinary care model for CKD patients Development cost-effective clinical care pathway for CKD 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: Explore risk factors associated with CKD: demographic, social and genetics factors Establish multidisciplinary care model for CKD patients Development cost-effective clinical care pathway for CKD Provide bio-specimen repository for future study: serum, PBMC, urine and stool

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

Keywords

risk factors, omics, multidisciplinary care

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

customary care

Arm Type

No Intervention

Arm Description

customary care for CKD

Arm Title

multidisciplinary care

Arm Type

Active Comparator

Arm Description

multidisciplinary team care for CKD

Intervention Type

Behavioral

Intervention Name(s)

multidisciplinary care

Intervention Description

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

Primary Outcome Measure Information:

Title

percentage (%)

Description

percentage of patients with new CKD, starting dialysis treatments, cardiovascular event or mortality

Time Frame

through study completion, every 1 year

Title

difference of US dollars

Description

differences of US dollars of medical care (out patients and inpatients service fees) between groups

Time Frame

through study completion, every 1 year

Secondary Outcome Measure Information:

Title

fold changes of proteins

Description

change of levels between groups

Time Frame

through study completion, every 1 year

Title

fold changes of microRNA

Description

change of levels between groups

Time Frame

through study completion, every 1 year

Other Pre-specified Outcome Measures:

Title

change of taxonomic units abundance of specific microbiota

Description

change of levels between groups

Time Frame

through study completion, every 1 year

Title

changes of metabolites

Description

change of levels between groups

Time Frame

through study completion, every 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tsang-Tang Hsieh

Phone

+886-2-27135211

Ext

3576

tth3388@adm.cgmh.org.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

I-Wen Wu

Organizational Affiliation

Chang Gung Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chang Gung Memorial Hospital

City

Keelung

ZIP/Postal Code

204

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

I-Wen Wu, MD

Phone

+886-2-24313131

Ext

3170

a22066@adm.cgmh.org.tw

12. IPD Sharing Statement

Citations:

PubMed Identifier

19491379

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.

Results Reference

result

PubMed Identifier

21414969

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.

Results Reference

result

Learn more about this trial

Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care

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