The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea
1 other identifier
interventional
40
1 country
1
Brief Summary
Basiliximab has been a routine induction therapeutic agent even for well-matched living kidney transplantation(KT) with tacrolimus-based immunosuppression in Korea. As tacrolimus is a different drug from cyclosporine, the investigators study the usefulness of tacrolimus-based immunosuppression without basiliximab in well matched living KT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedJune 2, 2015
May 1, 2015
3.2 years
April 28, 2015
May 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of rejection
The investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy.
within 3 years
Secondary Outcomes (1)
Incidence of infection
postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years
Study Arms (2)
No basiliximab group
EXPERIMENTALThe investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants.
Basilixiab group
ACTIVE COMPARATORAge and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group)
Interventions
Eligibility Criteria
You may qualify if:
- ABO compatible and T-flow negative transplants
- Living kidney transplantation
- Tacrolimus based immunosuppression
You may not qualify if:
- Multiorgan transplantation
- Zero-mismatch transplantation (we use cyclosporine instead of FK506)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Su-Kil Park, M.D, PhD
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 28, 2015
First Posted
June 2, 2015
Study Start
April 1, 2012
Primary Completion
June 1, 2015
Last Updated
June 2, 2015
Record last verified: 2015-05