AzTrials
AzTrials

End-Stage Renal DiseaseNCT00931970

Mode of Dialysis Therapy and Outcomes in End Stage Renal Disease (ESRD)

An observational study of End-Stage Renal Disease, run by Clinical Research Center for End Stage Renal Disease, Korea at 33 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is: 1. to compare complications and mortality of hemodialysis with those of peritoneal dialysis in Korean end stage renal disease (ESRD) patients; 2. to analyze the treatment effects on quality of life (QOL) by dialysis modality; and 3. to analyze cost-effectiveness by dialysis modality. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
End-Stage Renal Disease
How many people
5,400 participants
Where
33 sitesSouth Korea
Study dates
Jul 2009to Dec 2023
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Incident dialysis patients in Korea

Who may be able to join

  • Clinical diagnosis of end stage renal disease
  • Must be at least 20 years of age
  • Dialysis must be initiated in Korea
  • Informed consent

Who cannot join

  • Scheduled to receive kidney transplantation within 3 months
  • Scheduled to emigrate to foreign country within 3 months
  • Clinically suspected as acute renal failure

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

South Korea33 sites
  • Dong-A University Medical Center

    Busan

  • Inje University Pusan Paik Hospital

    Busan

  • Pusan National University Hospital

    Busan

  • Wallace Memorial Baptist Hospital

    Busan

  • Chungbuk National University Hospital

    Cheongju-si

  • Kyungpook National University Hospital

    Daegu, 41944

  • Daegu Fatima Hospital

    Daegu

  • Yeungnam University Medical Center

    Daegu

  • Chungnam National University Hospital

    Daejeon

  • Daejeon St. Mary's Hospital

    Daejeon

  • Holy Family Hospital

    Goyang-si

  • NHIC Ilsan Hospital

    Goyang-si

  • Chonnam National University Hospital

    Gwangju

  • Incheon St. Mary's Hospital

    Incheon

  • Cheju Halla General Hospital

    Jeju City

  • Chonbuk National University Hospital

    Jeonju

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • National Medical Center

    Seoul, 04564

  • Konkuk University

    Seoul, 05029

  • Seoul National University Boramae Medical Center

    Seoul, 07061

  • Ehwa Womans University Medical Center

    Seoul, 07985

  • Asan Medical Center

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul Medical Center

    Seoul

  • Seoul St. Mary's Hospital

    Seoul

  • St. Paul's Hospital

    Seoul

  • St. Vincent's Hospital

    Suwon

  • Uijeongbu St. Mary's Hospital

    Uijeongbu-si

  • Ulsan University Hospital

    Ulsan

  • Wonju Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

Official title: Comprehensive Prospective Study for Mode of Dialysis Therapy and Outcomes in ESRD

The purpose of this study is:

  1. to compare complications and mortality of hemodialysis with those of peritoneal dialysis in Korean end stage renal disease (ESRD) patients; 2. to analyze the treatment effects on quality of life (QOL) by dialysis modality; and 3. to analyze cost-effectiveness by dialysis modality.
Read the detailed description

The number of ESRD patients is growing at a much faster rate than the total population, with almost 1,000 (941.7) ESRD patients per one million as of 2006. The ESRD prevalence in Korea is ranked as high as 10th globally. The most common underlying diseases of ESRD in Korea include diabetes (42.3%), hypertension (16.9%), and chronic glomerulonephritis (13.0%). Diabetes and hypertension have been continuously increasing, as with a number of elderly patients due to population aging. From the examples of foreign countries with 2-to-3 fold larger dialysis population per million than Korea (ex. Japan, Taiwan, and the US), dialysis population here is forecasted to skyrocket. According to the 2003 data from the National Health Insurance Corporation that investigated diseases with high yearly treatment cost of over 5 million KRW, chronic renal failure (CRF) ranked first in both men and women. It was the single most expensive disease in 2000, with 212 billion KRW medical spending on 18,000 CRF patients, representing a significant burden to the national healthcare budget.

The ESRD Patient Registry run by the Korean Society of Nephrology (KSN) requires dialysis institutions to annually report the number of ESRD patients who receive renal replacement therapy, types of underlying disease, dialysis modality, and cause of death. Though the KSN statistics is useful as isolated epidemiological data, the program participation rate is only 60%, and cases of death are rarely reported. Clinical research on treatment or prognosis in CRF in Korea has mostly been performed by a single hospital or university, with no prospective, long-term, multi-center study performed yet.

The American Society of Nephrology, the National Kidney Foundation, and the American Association of Kidney Patients produce treatment guidelines based on effectiveness and safety proven through clinical trials. In the UK, NKRF and MRC have built databases on cardiovascular complications of chronic renal disease and outcomes with different treatment methods. Industrialized countries including the US, the UK, and Japan develop their standard treatment guidelines by thoroughly investigating etiology, progression, treatment, and cardiovascular complications and comparing effectiveness of known treatments.

The 5-year survival rate in ESRD patients in Korea is 37.8% for peritoneal dialysis patients and 65.2% for hemodialysis patients, respectively. There is a big discrepancy between patient's survival on HD and PD in Korea. However, it has been suspicious whether or not these survival data is convincing. QOL in maintenance dialysis patients is extremely low. Co-morbidity and time lost on dialysis makes it difficult to return to work while causing frequent hospitalization. Though their QOL might vary depending on country, culture, race, and dialysis modality, no multi-center study has been evaluated in Korea. CRF causes the largest per-patient health insurance reimbursement by the government, with the patient population continuously growing. Hospital stay is prolonged due to serious complications that require multi-disciplinary consultation drive up the medical cost. A cost-effectiveness study is urgently required. As in industrialized countries, the resources needed for development of the clinical practice guidelines are provided by the national government. "Effective clinical practice guidelines" will lower healthcare costs by preventing unnecessary medical practice and promote socioeconomic benefits and quality of care. The national government or related medical societies have yet to come up with a clinical practice guideline. Efforts should be made to work out "the KOREAN clinical practice guidelines" that will prevent clinical physicians from relying on foreign guidelines, which do not reflect the possibility of racial differences or was not proven to have effects on Koreans, and engaging in improper medical practices.

Our research contents are the same as below.

  1. Basic data input by dialysis modality.
  2. Collection of data on comorbidity and residual renal function at baseline.
  3. Collection of data on referral time and history of emergent dialysis.
  4. Comparative analysis of short-term QOL within 1 year of beginning dialysis.
  5. Comparative analysis of complications by dialysis modality.
  6. Comparative analysis of short-term patient/descriptive mortality and risk factors.
  7. Creation of infection prevention and treatment guidelines in dialysis patients.
  8. Comparative analysis of patient/descriptive mortality (3-year), complications, and risk factors by dialysis modality.
  9. Analysis of cost-effectiveness by dialysis modality: survival rates and QOL versus cost.
  10. Comparative analysis of residual renal function, its rate of decline, and survival rates by dialysis modality.
Keywords
Hemodialysis, Peritoneal dialysis, Mortality, Prospective cohort, Clinical study
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00931970
Study groupRoleWhat they receive
Dialysis modalityHemodialysis, Peritoneal dialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all cause mortality

    Survival

    Measured: Within the 4 weeks after the event

  2. Incidence of change/termination of treatment modality

    Incidence of change/termination dialysis modality

    Measured: Within the 4 weeks after the event

Secondary outcomes (7)
  1. Scores (ESKD-specific domain, physical (PCS) and mental (MCS) component summary scores) in health related quality of life mearused by the kidney disease quality of life (KDQOL)-Short Form (SF)

    Scores (ESKD-specific domain, physical (PCS) and mental (MCS) component summary scores) in health related quality of life mearused by in health related quality of life mearused by the kidney disease quality of life (KDQOL)-Short Form (SF)-Each domain is rated on a scale from 0 to 100, with higher scores reflecting better HRQOL. The scores of the ESRD-targeted items are aggregated into KDCS score. The scores of the 36-Item Short Form Health Survey, a patient-reported survey of patient health, are classified into PCS score that includes items related to physical function, physical roles, pain, and general health, as well as MCS score that includes items related to emotional roles, emotional wellbeing, emotional energy, and social functioning.

    Measured: One year

  2. Incidence of depressive symptom measured by the Beck Depression Inventory-II (BDI-II) (range: 0-63, higher scores mean worse depressive symptoms)

    Incidence of depressive symptom measured by the Beck Depression Inventory-II (BDI-II) (range: 0-63, higher scores mean worse depressive symptoms)

    Measured: One year

  3. Incidence of comorbidity measured by Charlson Comorbidity Index, Davies Comorbidity Index

    Incidence of comorbidity measured by Charlson Comorbidity Index, Davies Comorbidity Index

    Measured: One year

  4. Rate of preserved residual renal function

    Residual renal function-kt/v

    Measured: Six months

  5. Incidence of hospitalization episode and reason for hospitalization

    Incidence of hospitalization episode and reason for hospitalization

    Measured: Within the 4 weeks after the event

  6. Incidence of infection episode

    Incidence of infection episode

    Measured: Within the 4 weeks after the event

  7. Health cost

    Health cost

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Prospective
Enrolment
5,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931970
Sponsor's protocol ID
A-01
Status last verified
Apr 2022
First submitted
1 Jul 2009
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.

    PubMed 38899545
  • Jung HY, Jeon Y, Kim YS, Kang SW, Yang CW, Kim NH, Noh HW, Jeon SJ, Lim JH, Choi JY, Cho JH, Park SH, Kim CD, Kim YL. Sex disparities in mortality among patients with kidney failure receiving dialysis. Sci Rep. 2022 Nov 3;12(1):18555. doi: 10.1038/s41598-022-16163-w.

    PubMed 36329070
  • Oh HJ, Lee MJ, Lee HS, Park JT, Han SH, Yoo TH, Kim YL, Kim YS, Yang CW, Kim NH, Kang SW. NT-proBNP: is it a more significant risk factor for mortality than troponin T in incident hemodialysis patients? Medicine (Baltimore). 2014 Dec;93(27):e241. doi: 10.1097/MD.0000000000000241.

    PubMed 25501091
  • Choi JY, Jang HM, Park J, Kim YS, Kang SW, Yang CW, Kim NH, Cho JH, Park SH, Kim CD, Kim YL; Clinical Research Center for End Stage Renal Disease (CRC for ESRD) Investigators. Survival advantage of peritoneal dialysis relative to hemodialysis in the early period of incident dialysis patients: a nationwide prospective propensity-matched study in Korea. PLoS One. 2013 Dec 30;8(12):e84257. doi: 10.1371/journal.pone.0084257. eCollection 2013.

    PubMed 24386357

Questions about this trial

What is this clinical trial studying?

An observational study of End-Stage Renal Disease, run by Clinical Research Center for End Stage Renal Disease, Korea at 33 sites in South Korea.

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 4 inclusion and 3 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in South Korea. 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?

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?

Incidence of all cause mortality (time frame: Within the 4 weeks after the event). 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 NCT00931970, which also lists 4 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 12 Apr 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in