The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators omit basiliximab induction therapy in patients who underwent one to three-HLA mismatched living donor renal transplantation. Participants should receive ABO compatible and T-flow negative transplants. The investigators compare the results of intervention group with conventionally treated control group (age and sex matched patient who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy).

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Basiliximab
* Drug: No basiliximab
* Procedure: Kidney transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ABO compatible and T-flow negative transplants Living kidney transplantation Tacrolimus based immunosuppression Exclusion Criteria: Multiorgan transplantation Zero-mismatch transplantation (we use cyclosporine instead of FK506)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No basiliximab group<br>The investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants. | Drug: No basiliximab<br>* No basiliximab induction therapy<br>Procedure: Kidney transplantation<br>* kidney transplantation<br>|
| Active Comparator: Basilixiab group<br>Age and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group) | Drug: Basiliximab<br>* Basiliximab induction therapy<br>Procedure: Kidney transplantation<br>* kidney transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of rejection | The investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy. | within 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection | The investigators measures incidence of infection such as CMV, BKV infection, pneumonia, urinary tract infection and other infections. | postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years |