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The Effects of Pre-transplant Dialysis Modality on Post-transplant Events

NCT01513707 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1040

Last updated 2017-04-27

No results posted yet for this study

Summary

This is a prospective, multicenter, comparative, parallel-group, observational study. There will be 2 cohorts according to pre-transplant dialysis modality (hemodialysis or peritoneal dialysis). In each cohort, subjects will be observed for 12 months. Approximately, 1040 subjects will be enrolled from 8 transplant centers.

Subjects will be enrolled consecutively until the number of subjects in peritoneal dialysis group has been 260. It will take 2 years. In this period, the number of subject in hemodialysis group enrolled in this study will be 780. After finishing the observation of all subjects, to balance clinical and demographic baseline characteristics between the two groups, subjects will be selected in each cohort with 1:1 matched using propensity score method. And then primary and secondary endpoints will be compared between two groups.

Conditions

  • Delayed Function of Renal Transplant
  • Primary Nonfunction of Renal Transplant
  • Acute Rejection of Renal Transplant

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Ha Young Oh

    lead OTHER

Principal Investigators

  • Hayoung Oh · South Korea Samsung Medical Center

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-22
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513707 on ClinicalTrials.gov