Kidney Failure, ChronicPDKOREANCT02573675
An Assessment on Current Outcomes of Peritoneal Dialysis in Korea
An observational study of Kidney Failure, Chronic, run by Ewha Womans University.
Trial summary
In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Failure, Chronic
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Oct 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All incident dialysis patients who started chronic dialysis therapy between January 1, 2009 and December 31, 2014 in Korea
Who may be able to join
- Patients who started dialysis during the study period and remained on the dialysis therapy for at least 90 days
Who cannot join
- Patients who were younger than 18 years of age
- Patients who survived for less than 90 days from the date of dialysis initiation
About this study
In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will be investigated retrospectively using the Korean Health Insurance Review and Assessment Service (HIRA) database.
Read the detailed description
This study is designed as an observational and retrospective cohort study, thus there will be no intervention or specified prescription.
For the comparison of outcomes according to dialysis modality, we will adopt an intention-to-treat analysis, and consider the dialysis modality at day 90 to be the initial dialysis modality. However, the investigators will also regard the dialysis modality at day 30 as the initial dialysis modality in order to evaluate and compare earlier mortality.
- Conditions
- Kidney Failure, Chronic
- Keywords
- hemodialysis, peritoneal dialysis
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate according to dialysis modality
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573675
- Sponsor's protocol ID
- PDKOREA-1
- Acronym
- PDKOREA
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim H, Kim KH, Park K, Kang SW, Yoo TH, Ahn SV, Ahn HS, Hann HJ, Lee S, Ryu JH, Kim SJ, Kang DH, Choi KB, Ryu DR. A population-based approach indicates an overall higher patient mortality with peritoneal dialysis compared to hemodialysis in Korea. Kidney Int. 2014 Nov;86(5):991-1000. doi: 10.1038/ki.2014.163. Epub 2014 May 7.
PubMed 24805104
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment on Current Outcomes of Peritoneal Dialysis in Korea
- ClinicalTrials.gov ID
- NCT02573675
- Acronym / sponsor ID
- PDKOREA / PDKOREA-1
- Conditions
- Kidney Failure, Chronic
- Keywords
- hemodialysis, peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- 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.
In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will be investigated retrospectively using the Korean Health Insurance Review and Assessment Service (HIRA) database.
Detailed description
This study is designed as an observational and retrospective cohort study, thus there will be no intervention or specified prescription.
For the comparison of outcomes according to dialysis modality, we will adopt an intention-to-treat analysis, and consider the dialysis modality at day 90 to be the initial dialysis modality. However, the investigators will also regard the dialysis modality at day 30 as the initial dialysis modality in order to evaluate and compare earlier mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All incident dialysis patients who started chronic dialysis therapy between January 1, 2009 and December 31, 2014 in Korea
Key inclusion criteria (1 listed)
- Patients who started dialysis during the study period and remained on the dialysis therapy for at least 90 days
Key exclusion criteria (2 listed)
- Patients who were younger than 18 years of age
- Patients who survived for less than 90 days from the date of dialysis initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival rate according to dialysis modality
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Background: PubMed 24805104Kim H, Kim KH, Park K, Kang SW, Yoo TH, Ahn SV, Ahn HS, Hann HJ, Lee S, Ryu JH, Kim SJ, Kang DH, Choi KB, Ryu DR. A population-based approach indicates an overall higher patient mortality with peritoneal dialysis compared to hemodialysis in Korea. Kidney Int. 2014 Nov;86(5):991-1000. doi: 10.1038/ki.2014.163. Epub 2014 May 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by Ewha Womans University.
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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate according to dialysis modality (time frame: up to 5 years). 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 NCT02573675, which also lists 1 linked publication.
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 12 Oct 2015.