Status:
UNKNOWN
The Effects of Pre-transplant Dialysis Modality on Post-transplant Events
Lead Sponsor:
Ha Young Oh
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Delayed Function of Renal Transplant
Primary Nonfunction of Renal Transplant
Eligibility:
All Genders
20-70 years
Brief 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 ea...
Detailed Description
1\. STUDY OBJECTIVES AND ENDPOINTS 1.1. Objectives The primary objective of this study is: • To compare the incidence of composite outcomes (delayed graft function, functional delayed graft function...
Eligibility Criteria
Inclusion
- Subjects must have end-stage renal disease, have been on one renal replacement therapy (hemodialysis or peritoneal dialysis) for \> 6 months ( Who had been on hemodialysis for at least 6 months before renal transplant for the hemodialysis group; Who had been on peritoneal dialysis for at least 6 months before renal transplant for the peritoneal dialysis group ), and are scheduled to receive a first kidney transplant from a deceased donor, a living-related donor, or a living-unrelated donor.
- Between the ages of 20 and 70 years, inclusive.
- Either female or male adults
- Subjects must be willing and able to provide written personal information consent with evidence of a personally signed and dated personal information consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion
- Subjects who had combined dialysis (hemodialysis + peritoneal dialysis simultaneously).
- Subjects who are recipients for multiple organ transplant.
- Subjects scheduled for non-heart beating donor transplantation.
- Subjects scheduled for transplantation using desensitization (plasmapheresis + Rituximab) process.
- Subjects with evidence of active infection.
- Women of childbearing potential who are either pregnant, lactating, planning to become pregnant in the next 12 months. Women of childbearing potential must be willing to agree to contraceptive practices.
Key Trial Info
Start Date :
December 22 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
1040 Patients enrolled
Trial Details
Trial ID
NCT01513707
Start Date
December 22 2011
End Date
December 1 2017
Last Update
April 27 2017
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710