Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care

March 6, 2020 updated by: I Wen Wu, MD, Chang Gung Memorial Hospital

Biomarker and Multidisciplinary Predialysis Education in Chronic Kidney Disease Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

8000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Keelung, Taiwan, 204
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient receiving dialysis or transplantation
  • Unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: customary care
customary care for CKD
Active Comparator: multidisciplinary care
multidisciplinary team care for CKD
Behavioral: multidisciplinary care
multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage (%)
Time Frame: through study completion, every 1 year
percentage of patients with new CKD, starting dialysis treatments, cardiovascular event or mortality
through study completion, every 1 year
difference of US dollars
Time Frame: through study completion, every 1 year
differences of US dollars of medical care (out patients and inpatients service fees) between groups
through study completion, every 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fold changes of proteins
Time Frame: through study completion, every 1 year
change of levels between groups
through study completion, every 1 year
fold changes of microRNA
Time Frame: through study completion, every 1 year
change of levels between groups
through study completion, every 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of taxonomic units abundance of specific microbiota
Time Frame: through study completion, every 1 year
change of levels between groups
through study completion, every 1 year
changes of metabolites
Time Frame: through study completion, every 1 year
change of levels between groups
through study completion, every 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Science and Technology, Taiwan

Investigators

  • Principal Investigator: I-Wen Wu, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IWW-0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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