Mode of Dialysis Therapy and Outcomes in End Stage Renal Disease (ESRD)
This study is currently recruiting participants.
Verified February 2013 by Clinical Research Center for End Stage Renal Disease, Korea
Sponsor:
Clinical Research Center for End Stage Renal Disease, Korea
Collaborators:
Ministry of Health & Welfare, Korea
Kyungpook National University
Daegu Metropolitan City, Korea
National Clinical Research Coordination Center, Seoul, Korea
Medical Research Collaborating Center, Seoul, Korea
Information provided by:
Clinical Research Center for End Stage Renal Disease, Korea
ClinicalTrials.gov Identifier:
NCT00931970
First received: July 1, 2009
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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;
- to analyze the treatment effects on quality of life (QOL) by dialysis modality; and
- to analyze cost-effectiveness by dialysis modality.
| Condition |
|---|
|
End-Stage Renal Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Comprehensive Prospective Study for Mode of Dialysis Therapy and Outcomes in ESRD |
Resource links provided by NLM:
Further study details as provided by Clinical Research Center for End Stage Renal Disease, Korea:
Primary Outcome Measures:
- All cause mortality and change/termination of treatment modality [ Time Frame: Within the 4 weeks after the event ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
- Compliance and satisfaction [ Time Frame: One year ] [ Designated as safety issue: No ]
- Empowerment and depression [ Time Frame: One year ] [ Designated as safety issue: No ]
- Performance status [ Time Frame: One year ] [ Designated as safety issue: No ]
- Comorbidity indices [ Time Frame: One year ] [ Designated as safety issue: No ]
- Residual renal function [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Hospitalization episode and reason for hospitalization [ Time Frame: Within the 4 weeks after the event ] [ Designated as safety issue: No ]
- Infection episode [ Time Frame: Within the 4 weeks after the event ] [ Designated as safety issue: No ]
- Health cost [ Time Frame: One year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum Whole blood Urine Dialysate
| Estimated Enrollment: | 5000 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Dialysis modality |
Show Detailed Description Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Incident dialysis patients in Korea
Criteria
Inclusion Criteria:
- Clinical diagnosis of end stage renal disease
- Must be at least 20 years of age
- Dialysis must be initiated in Korea
- Informed consent
Exclusion Criteria:
- Scheduled to receive kidney transplantation within 3 months
- Scheduled to emigrate to foreign country within 3 months
- Clinically suspected as acute renal failure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931970
Contacts
| Contact: Ji-Young Choi, M.D. | +82-10-8584-8557 | jyss1002@hanmail.net |
| Contact: Jung-Ju Seo, Ms | +82-53-420-6305 | crc_esrd@knu.ac.kr |
Locations
| Korea, Republic of | |
| Wonju Christian Hospital | Not yet recruiting |
| Wonju-si, Gangwon-do, Korea, Republic of, 220-701 | |
| Contact: Byoung Geun Han, M.D., Ph.D. +82-33-741-1240 neptune@yonsei.ac.kr | |
| Holy Family Hospital | Recruiting |
| Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-717 | |
| Contact: Yong Kyun Kim, M.D. +82-32-340-7569 drkimyk@hanmail.net | |
| NHIC Ilsan Hospital | Not yet recruiting |
| Goyang-si, Gyeonggi-do, Korea, Republic of, 410-719 | |
| Contact: Seung Hyeok Han, M.D., Ph.D. +82-31-900-0246 anythingbox70@hotmail.com | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 | |
| Contact: Ho Jun Jin, M.D., Ph.D. +82-31-787-7025 mednep@snubh.org | |
| St. Vincent's Hospital | Recruiting |
| Suwonsi, Gyeonggi-do, Korea, Republic of, 442-723 | |
| Contact: Hyung Wook Kim, M.D. +82-31-249-7114 khw@catholic.ac.kr | |
| Uijeongbu St. Mary's Hospital | Recruiting |
| Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 480-130 | |
| Contact: Sun Ae Yoon, M.D., Ph.D. +82-31-820-3025 sayoon@catholic.ac.kr | |
| Pusan National University Hospital | Recruiting |
| Busan, Korea, Republic of, 602-739 | |
| Contact: Sang Heon Song, M.D., Ph.D. +82-51-240-7225 shsong@pusan.ac.kr | |
| Dong-A University Medical Center | Recruiting |
| Busan, Korea, Republic of, 602-715 | |
| Contact: Seong Eun Kim, M.D., Ph.D. +82-51-240-2963 sekim@dau.ac.kr | |
| Wallace Memorial Baptist Hospital | Not yet recruiting |
| Busan, Korea, Republic of, 609-728 | |
| Contact: Bo Jeung Seo, M.D. +82-51-580-1256 sbj@wmbh.co.kr | |
| Inje University Pusan Paik Hospital | Recruiting |
| Busan, Korea, Republic of, 614-735 | |
| Contact: Yeong Hoon Kim, M.D., Ph.D. +82-51-890-6264 yeonghnk@hotmail.com | |
| Chungbuk National University Hospital | Recruiting |
| Cheongju, Korea, Republic of, 361-790 | |
| Contact: Hye-Young Kim, M.D., Ph.D. +82-43-269-6017 hyekim@chungbuk.ac.kr | |
| Kyungpook National University Hospital | Recruiting |
| Daegu, Korea, Republic of, 700-721 | |
| Contact: Ji-Young Choi, M.D. +82-11-9584-8557 jyss1002@hanmail.net | |
| Contact: Jung-Ju Seo, Ms +82-53-420-6305 crc_esrd@knu.ac.kr | |
| Principal Investigator: Yong-Lim Kim, M.D., Ph.D. | |
| Daegu Fatima Hospital | Recruiting |
| Daegu, Korea, Republic of, 701-600 | |
| Contact: Sung-Ho Kim, M.D., Ph.D. +82-53-940-7221 shkim@fatima.or.kr | |
| Yeungnam University Medical Center | Recruiting |
| Daegu, Korea, Republic of, 705-717 | |
| Contact: Jun-Young Do, M.D., Ph.D. +82-53-620-3844 jydo@med.yu.ac.kr | |
| Daejeon St. Mary's Hospital | Not yet recruiting |
| Daejeon, Korea, Republic of, 301-723 | |
| Contact: Suk Young Kim, M.D., Ph.D. +82-42-220-9836 alterego54@catholic.ac.kr | |
| Chungnam National University Hospital | Recruiting |
| Daejeon, Korea, Republic of, 301-721 | |
| Contact: Kang Wook Lee, M.D., Ph.D. +82-42-280-7160 kwlee@cnu.ac.kr | |
| Chonnam National University Hospital | Recruiting |
| Gwangju, Korea, Republic of, 501-757 | |
| Contact: Nam-Ho Kim, M.D., Ph.D. +82-62-220-6270 nhk111@chonnam.ac.kr | |
| Contact: Pyoeng Gyun Park, M.D. +82-11-620-9241 apppk@naver.com | |
| Sub-Investigator: Nam-Ho Kim, M.D., Ph.D. | |
| Incheon St. Mary's Hospital | Not yet recruiting |
| In Cheon, Korea, Republic of, 403-720 | |
| Contact: Hyun Hwa Chung, M.D. +82-32-510-5500 zoo430@catholic.ac.kr | |
| Cheju Halla General Hospital | Recruiting |
| Jeju-si, Korea, Republic of, 690-766 | |
| Contact: Chungsik Lee, M.D. +82-64-740-5000 jaeut@naver.com | |
| Chonbuk National University Hospital | Recruiting |
| Jeonju-si, Korea, Republic of, 561-712 | |
| Contact: Won Kim, M.D., Ph.D. +82-63-250-1651 kwon@chonbuk.ac.kr | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Yon Su Kim, M.D., Ph.D +82-2-2072-2264 yonsukim@snu.ac.kr | |
| Contact: Jeong Pyo Lee, M.D. +82-17-737-4554 kjwa1@medimail.co.kr | |
| Sub-Investigator: Yon Su Kim, M.D., Ph.D. | |
| St. Mary's Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 150-713 | |
| Contact: Yoon Sik Chang, M.D., Ph.D. +82-2-3779-1259 ysc543@unitel.co.kr | |
| Samsung Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Dae Joong Kim, M.D., Ph.D. +82-2-3410-3441 daejoongsmc.kim@samsung.com | |
| Gangnam Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 135-720 | |
| Contact: Hyeong Cheon Park, M.D., Ph.D. +82-2-2019-3310 amp97@yuhs.ac | |
| Asan Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Soon Bae Kim, M.D., Ph.D. +82-2-3010-3264 sbkim@amc.seoul.kr | |
| St. Paul's Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 130-701 | |
| Contact: Byung Su Kim, M.D., Ph.D. +82-2-958-2491 kbsnep@catholic.ac.kr | |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Recruiting |
| Seoul, Korea, Republic of, 156-707 | |
| Contact: Yun Kyu Oh, M.D., Ph.D. +82-2-870-2219 yoonkyu@snu.ac.kr | |
| Ewha Womans University Mokdong Hospital | Recruiting |
| Seoul, Korea, Republic of, 158-710 | |
| Contact: Dong-Ryeol Ryu, M.D., Ph.D. +82-2-2650-2507 drryu@ewha.ac.kr | |
| Seoul St. Mary's Hospital | Recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Contact: Chul Woo Yang, M.D., Ph.D. +82-2-590-2527 yangch@catholic.ac.kr | |
| Contact: Bum Soon Choi, M.D., Ph.D. +82-2-2258-7570 sooncb@catholic.ac.kr | |
| Sub-Investigator: Chul Woo Yang, M.D., Ph.D. | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Shin-Wook Kang, M.D., Ph.D. +82-2-2228-1959 kswkidney@yumc.yonsei.ac.kr | |
| Contact: Jung Tak Park, M.D. +82-11-9042-9639 jtpark@yuhs.ac | |
| Sub-Investigator: Shin-Wook Kang, M.D., Ph.D. | |
| Seoul Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 135-740 | |
| Contact: Na Ree Kang, M.D. +82-2-3430-0603 narikg@hanmail.net | |
| Chung-Ang University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 140-757 | |
| Contact: Dong Jin Oh, M.D., Ph.D. +82-2-6299-1402 intmdoh@hanmail.net | |
| Ulsan University Hospital | Recruiting |
| Ulsan, Korea, Republic of, 682-714 | |
| Contact: Jong-Soo Lee, M.D., Ph.D. +82-52-250-8843 jslee@uuh.ulsan.kr | |
Sponsors and Collaborators
Clinical Research Center for End Stage Renal Disease, Korea
Ministry of Health & Welfare, Korea
Kyungpook National University
Daegu Metropolitan City, Korea
National Clinical Research Coordination Center, Seoul, Korea
Medical Research Collaborating Center, Seoul, Korea
Investigators
| Principal Investigator: | Yong-Lim Kim, M.D., Ph.D. | Division of Nephrology and Department of Internal Medicine, Kyungpook National Univerisity Hospital, Daegu, Korea |
More Information
Additional Information:
No publications provided
| Responsible Party: | Yong-Lim Kim, Clinical Research Center for End Stage Renal Disease, Korea |
| ClinicalTrials.gov Identifier: | NCT00931970 History of Changes |
| Other Study ID Numbers: | A-01 |
| Study First Received: | July 1, 2009 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Korea: Ministry for Health, Welfare and Family Affairs |
Keywords provided by Clinical Research Center for End Stage Renal Disease, Korea:
|
Hemodialysis Peritoneal Dialysis Mortality |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013