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.
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
About this study
Official title: Comprehensive Prospective Study for Mode of Dialysis Therapy and Outcomes in ESRD
The purpose of this study is:
- 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.
- Basic data input by dialysis modality.
- Collection of data on comorbidity and residual renal function at baseline.
- Collection of data on referral time and history of emergent dialysis.
- Comparative analysis of short-term QOL within 1 year of beginning dialysis.
- Comparative analysis of complications by dialysis modality.
- Comparative analysis of short-term patient/descriptive mortality and risk factors.
- Creation of infection prevention and treatment guidelines in dialysis patients.
- Comparative analysis of patient/descriptive mortality (3-year), complications, and risk factors by dialysis modality.
- Analysis of cost-effectiveness by dialysis modality: survival rates and QOL versus cost.
- Comparative analysis of residual renal function, its rate of decline, and survival rates by dialysis modality.
- Conditions
- End-Stage Renal Disease
- 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 group | Role | What they receive |
|---|---|---|
| Dialysis modality | Hemodialysis, Peritoneal dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all cause mortality
Survival
Measured: Within the 4 weeks after the event
Incidence of change/termination of treatment modality
Incidence of change/termination dialysis modality
Measured: Within the 4 weeks after the event
Secondary outcomes (7)
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
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
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
Rate of preserved residual renal function
Residual renal function-kt/v
Measured: Six months
Incidence of hospitalization episode and reason for hospitalization
Incidence of hospitalization episode and reason for hospitalization
Measured: Within the 4 weeks after the event
Incidence of infection episode
Incidence of infection episode
Measured: Within the 4 weeks after the event
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.
- First posted2 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center for End Stage Renal Disease, Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Kyungpook National University Hospital, Daegu Metropolitan City, Korea, National Clinical Research Coordination Center, Seoul, Korea, Medical Research Collaborating Center, Seoul, Korea
- Responsible party
- Principal investigator, Yong-Lim Kim, Clinical Research Center for End Stage Renal Disease, Korea
- Investigators
- Yong-Lim Kim, M.D., Ph.D., Principal investigator, Division of Nephrology and Department of Internal Medicine, Kyungpook National Univerisity Hospital, Daegu, Korea
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 38899545Jung 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 36329070Oh 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 25501091Choi 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Prospective Study for Mode of Dialysis Therapy and Outcomes in ESRD
- ClinicalTrials.gov ID
- NCT00931970
- Acronym / sponsor ID
- A-01
- Conditions
- End-Stage Renal Disease
- Keywords
- Hemodialysis, Peritoneal dialysis, Mortality, Prospective cohort, Clinical study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Clinical Research Center for End Stage Renal Disease, KoreaUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Kyungpook National University Hospital, Daegu Metropolitan City, Korea, National Clinical Research Coordination Center, Seoul, Korea, Medical Research Collaborating Center, Seoul, Korea
- Study start
- Jul 2009
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jul 2009 (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.
The purpose of this study is:
- 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.
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.
- Basic data input by dialysis modality.
- Collection of data on comorbidity and residual renal function at baseline.
- Collection of data on referral time and history of emergent dialysis.
- Comparative analysis of short-term QOL within 1 year of beginning dialysis.
- Comparative analysis of complications by dialysis modality.
- Comparative analysis of short-term patient/descriptive mortality and risk factors.
- Creation of infection prevention and treatment guidelines in dialysis patients.
- Comparative analysis of patient/descriptive mortality (3-year), complications, and risk factors by dialysis modality.
- Analysis of cost-effectiveness by dialysis modality: survival rates and QOL versus cost.
- Comparative analysis of residual renal function, its rate of decline, and survival rates by dialysis modality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis modality | – | –Hemodialysis, Peritoneal dialysis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident dialysis patients in Korea
Key inclusion criteria (4 listed)
- Clinical diagnosis of end stage renal disease
- Must be at least 20 years of age
- Dialysis must be initiated in Korea
- Informed consent
Key exclusion criteria (3 listed)
- Scheduled to receive kidney transplantation within 3 months
- Scheduled to emigrate to foreign country within 3 months
- Clinically suspected as acute renal failure
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
Incidence of all cause mortality
Time frame: Within the 4 weeks after the event
Survival
Incidence of change/termination of treatment modality
Time frame: Within the 4 weeks after the event
Incidence of change/termination dialysis modality
7 secondary outcomes
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)
Time frame: One year
Incidence of depressive symptom measured by the Beck Depression Inventory-II (BDI-II) (range: 0-63, higher scores mean worse depressive symptoms)
Time frame: One year
Incidence of comorbidity measured by Charlson Comorbidity Index, Davies Comorbidity Index
Time frame: One year
Rate of preserved residual renal function
Time frame: Six months
Incidence of hospitalization episode and reason for hospitalization
Time frame: Within the 4 weeks after the event
Incidence of infection episode
Time frame: Within the 4 weeks after the event
Health cost
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 38899545Ethier 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.
- Derived from this study: PubMed 36329070Jung 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.
- Derived from this study: PubMed 25501091Oh 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.
- Derived from this study: PubMed 24386357Choi 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.
- Individual participant dataSharing planned: No
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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.
Yong-Lim Kim, M.D., Ph.D. principal investigator
Division of Nephrology and Department of Internal Medicine, Kyungpook National Univerisity Hospital, Daegu, Korea
33 sites in 1 country: see every site and its status.
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.