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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Clinical Research Center for End Stage Renal Disease, Korea
Sponsor:
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 (Responsible Party):
Ji-Hyung Cho, Clinical Research Center for End Stage Renal Disease, Korea
ClinicalTrials.gov Identifier:
NCT00931970
First received: July 1, 2009
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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   
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   
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   
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   
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   
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.         
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   
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   
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   
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   
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   
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   
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   
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   
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   
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   
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.         
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.         
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   
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 by Clinical Research Center for End Stage Renal Disease, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ji-Hyung Cho, professor, 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: January 29, 2014
Health Authority: Korea: Ministry for Health and Welfare

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
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 23, 2014