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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00931970
Recruitment Status : Unknown
Verified March 2018 by Yong-Lim Kim, Clinical Research Center for End Stage Renal Disease, Korea.
Recruitment status was:  Recruiting
First Posted : July 2, 2009
Last Update Posted : March 8, 2018
Sponsor:
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
Information provided by (Responsible Party):
Yong-Lim Kim, Clinical Research Center for End Stage Renal Disease, Korea

Brief 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.


Condition or disease
End-Stage Renal Disease

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 5400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Prospective Study for Mode of Dialysis Therapy and Outcomes in ESRD
Study Start Date : July 2009
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Dialysis modality



Primary Outcome Measures :
  1. All cause mortality and change/termination of treatment modality [ Time Frame: Within the 4 weeks after the event ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: One year ]
  2. Compliance and satisfaction [ Time Frame: One year ]
  3. Empowerment and depression [ Time Frame: One year ]
  4. Performance status [ Time Frame: One year ]
  5. Comorbidity indices [ Time Frame: One year ]
  6. Residual renal function [ Time Frame: Six months ]
  7. Hospitalization episode and reason for hospitalization [ Time Frame: Within the 4 weeks after the event ]
  8. Infection episode [ Time Frame: Within the 4 weeks after the event ]
  9. Health cost [ Time Frame: One year ]

Biospecimen Retention:   Samples With DNA
Serum Whole blood Urine Dialysate


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931970


Contacts
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Contact: Hee-Yeon Jung, M.D. 83mayring@hanmail.net
Contact: Kyong Suk Seo, Ms +82-53-200-5946 crc_esrd@knu.ac.kr

Locations
Show Show 33 study locations
Sponsors and Collaborators
Clinical Research Center for End Stage Renal Disease, Korea
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
Investigators
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Principal Investigator: Yong-Lim Kim, M.D., Ph.D. Division of Nephrology and Department of Internal Medicine, Kyungpook National Univerisity Hospital, Daegu, Korea
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yong-Lim Kim, Professor, Clinical Research Center for End Stage Renal Disease, Korea
ClinicalTrials.gov Identifier: NCT00931970    
Other Study ID Numbers: A-01
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yong-Lim Kim, Clinical Research Center for End Stage Renal Disease, Korea:
Hemodialysis
Peritoneal dialysis
Mortality
Prospective cohort
Clinical study
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency