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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 July 2016 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):
Yong-Lim Kim, Clinical Research Center for End Stage Renal Disease, Korea
ClinicalTrials.gov Identifier:
NCT00931970
First received: July 1, 2009
Last updated: July 11, 2016
Last verified: July 2016
  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: 5400
Study Start Date: July 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dialysis modality

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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: Hee-Yeon Jung, M.D. 83mayring@hanmail.net
Contact: Kyong Suk Seo, Ms +82-53-200-5946 crc_esrd@knu.ac.kr

Locations
Korea, Republic of
Dong-A University Medical Center Recruiting
Busan, Korea, Republic of
Contact: Seong Eun Kim, M.D., Ph.D.    +82-51-240-2963    sekim@dau.ac.kr   
Inje University Pusan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Yeong Hoon Kim, M.D., Ph.D.    +82-51-890-6264    yeonghnk@hotmail.com   
Pusan National University Hospital Recruiting
Busan, Korea, Republic of
Contact: Sang Heon Song, M.D., Ph.D.    +82-51-240-7225    shsong@pusan.ac.kr   
Wallace Memorial Baptist Hospital Recruiting
Busan, Korea, Republic of
Contact: Bo Jeung Seo, M.D.    +82-51-580-1256    sbj@wmbh.co.kr   
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of
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, 41944
Contact: Jang-Hee Cho, M.D.       jh-cho@knu.ac.kr   
Contact: Kyong Suk Seo, Ms    +82-53-200-5946    crc_esrd@knu.ac.kr   
Principal Investigator: Yong-Lim Kim, M.D., Ph.D.         
Daegu Fatima Hospital Recruiting
Daegu, Korea, Republic of
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
Contact: Jun-Young Do    +82-53-620-3844    jydo@med.yu.ac.kr   
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Kang Wook Lee, M.D., Ph.D.    +82-42-280-7160    kwlee@cnu.ac.kr   
Daejeon St. Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Suk Young Kim, M.D., Ph.D.    +82-42-220-9836    alterego54@catholic.ac.kr   
Holy Family Hospital Recruiting
Goyang-si, Korea, Republic of
Contact: Yong Kyun Kim, M.D.    +82-32-340-7569    drkimyk@hanmail.net   
NHIC Ilsan Hospital Recruiting
Goyang-si, Korea, Republic of
Contact: Seung Hyeok Han, M.D., Ph.D.       anythingbox70@hotmail.com   
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Nam-Ho Kim, M.D., Ph.D.    +82-62-220-6270    nhk111@chonnam.ac.kr   
Incheon St. Mary's Hospital Recruiting
Incheon, Korea, Republic of
Contact: Hyun Hwa Chung    +82-32-510-5500    zoo430@catholic.ac.kr   
Cheju Halla General Hospital Recruiting
Jeju-si, Korea, Republic of
Contact: Chungsik Lee, M.D.    +82-64-740-5000    jaeut@naver.com   
Chonbuk National University Hospital Recruiting
Jeonju-si, Korea, Republic of
Contact: Won Kim, M.D., Ph.D.    +82-63-250-1651    kwon@chonbuk.ac.kr   
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of
Contact: Ho Jun Jin, M.D., Ph.D.    +82-31-787-7025    mednep@snubh.org   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Yon Su Kim, M.D., Ph.D    +82-2-2072-2264    yonsukim@snu.ac.kr   
Sub-Investigator: Yon Su Kim, M.D., Ph.D.         
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Shin-Wook Kang, M.D., Ph.D.    +82-2-2228-1959    kswkidney@yuhs.ac   
Contact: Jung Tak Park, M.D.    +82-2-2228-1978    jtpark@yuhs.ac   
Sub-Investigator: Shin-Wook Kang, M.D., Ph.D.         
National Medical Center Recruiting
Seoul, Korea, Republic of, 04564
Contact: Ran-Hui Cha, M.D., Ph.D.    +82-2-2262-4885    reginaprayer@gmail.com   
Konkuk University Recruiting
Seoul, Korea, Republic of, 05029
Contact: Keon Se Lee, M.D., Ph.D.    +82-2-2030-7817    leekonkuk@gmail.com   
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 07061
Contact: Jung Pyo Lee, M.D., Ph.D.    +82-2-870-3206    nephrolee@gmail.com   
Sub-Investigator: Jung Pyo Lee, M.D., Ph.D.         
Ehwa Womans University Medical Center Recruiting
Seoul, Korea, Republic of, 07985
Contact: Dong Ryeol Ryu, M.D., Ph.D.    +82-2-2650-2507    drryu@ewha.ac.kr   
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Soon Bae Kim, M.D., Ph.D.    +82-2-3010-3264    sbkim@amc.seoul.kr   
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyeong Cheon Park    +82-2-2019-3310    amp97@yuhs.ac   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Dae Joong Kim, M.D., Ph.D.    +82-2-3410-3441    daejoongsmc.kim@samsung.com   
Seoul Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Na Ree Kang, M.D.    +82-2-3430-0603    narikg@hanmail.net   
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chul Woo Yang, M.D., Ph.D.    +82-2-590-2527    yangch@catholic.ac.kr   
Contact: Byung Ha Chung, M.D., Ph.D.       chungbh@catholic.ac.kr   
Sub-Investigator: Chul Woo Yang, M.D., Ph.D.         
St. Paul's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byung Su Kim, M.D., Ph.D.    +82-2-958-2491    kbsnep@catholic.ac.kr   
St. Vincent's Hospital Recruiting
Suwonsi, Korea, Republic of
Contact: Hyung Wook Kim, M.D.    +82-31-249-7114    khw@catholic.ac.kr   
Uijeongbu St. Mary's Hospital Recruiting
Uijeongbu-si, Korea, Republic of
Contact: Sun Ae Yoon, M.D., Ph.D.    +82-31-820-3025    sayoon@catholic.ac.kr   
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Jong-Soo Lee, M.D., Ph.D.    +82-52-250-8843    jslee@uuh.ulsan.kr   
Wonju Christian Hospital Recruiting
Wonju-si, Korea, Republic of
Contact: Byoung Geun Han, M.D., Ph.D.    +82-33-741-1240    neptune@yonsei.ac.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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yong-Lim Kim, 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: July 11, 2016
Health Authority: Korea: Ministry for Health and Welfare
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Clinical Research Center for End Stage Renal Disease, Korea:
Hemodialysis
Peritoneal dialysis
Mortality
Prospective cohort
Clinical study

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 23, 2016