Chronic Kidney DiseaseNCT04300387
Chronic Kidney Disease at Northeast Taiwan: Biomarker and Multidisciplinary Care
A study testing multidisciplinary care in people with Chronic Kidney Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- multidisciplinary care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects visiting outpatient clinics of nephrology of Chang Gung Memorial Hospital
Who cannot join
- Patient receiving dialysis or transplantation
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Keelung, 204
I-Wen Wu, MD, +886-2-24313131 ext. 3170, a22066@adm.cgmh.org.tw
About this study
Official title: 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:
- 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
Read the 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
- Conditions
- Chronic Kidney Disease
- Being tested
- multidisciplinary care
- Keywords
- risk factors, omics, multidisciplinary care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary careBehavioural
multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.
| Study group | Role | What they receive |
|---|---|---|
| customary care | No intervention | customary care for CKD |
| multidisciplinary care | Active comparator | multidisciplinary team care for CKD Receives: Behavioral: multidisciplinary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage (%)
percentage of patients with new CKD, starting dialysis treatments, cardiovascular event or mortality
Measured: through study completion, every 1 year
difference of US dollars
differences of US dollars of medical care (out patients and inpatients service fees) between groups
Measured: through study completion, every 1 year
Secondary outcomes (2)
fold changes of proteins
change of levels between groups
Measured: through study completion, every 1 year
fold changes of microRNA
change of levels between groups
Measured: through study completion, every 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study startMar 2011
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, I Wen Wu, MD, Chang Gung Memorial Hospital
- Investigators
- I-Wen Wu, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300387
- Sponsor's protocol ID
- IWW-0005
- Status last verified
- Mar 2020
- First submitted
- 30 Sep 2016
- Last updated
- 9 Mar 2020
- Results posted
- No
Publications
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.
PubMed 19491379Chen 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.
PubMed 21414969
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker and Multidisciplinary Predialysis Education in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT04300387
- Acronym / sponsor ID
- IWW-0005
- Conditions
- Chronic Kidney Disease
- Keywords
- risk factors, omics, multidisciplinary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| customary care | No intervention | –customary care for CKD |
| multidisciplinary care | Active comparator | Behavioral: multidisciplinary caremultidisciplinary team care for CKD |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects visiting outpatient clinics of nephrology of Chang Gung Memorial Hospital
Key exclusion criteria (2 listed)
- Patient receiving dialysis or transplantation
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary caremultidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists. | Behavioural | multidisciplinary care |
Primary outcome
percentage (%)
Time frame: through study completion, every 1 year
percentage of patients with new CKD, starting dialysis treatments, cardiovascular event or mortality
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
2 secondary outcomes
fold changes of proteins
Time frame: through study completion, every 1 year
fold changes of microRNA
Time frame: through study completion, every 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Results publication: PubMed 19491379Wu 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 publication: PubMed 21414969Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Wen Wu principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary care in people with Chronic Kidney Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsang-Tang Hsieh (+886-2-27135211 ext. 3576, tth3388@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage (%) (time frame: through study completion, every 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.