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

Not Applicable

• Conditions: Kidney Transplantation
• Interventions: Drug: No basiliximab; Drug: Basiliximab; Procedure: Kidney transplantation

• Registration Number: NCT02459977
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

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).

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2015-04-28
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-29
• Last Update Submitted: 2015-05-29
• Primary Completion: 2015-06
• Study First Posted: 2015-06-02
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No basiliximab group	No basiliximab	The investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants.
No basiliximab group	Kidney transplantation	The investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants.
Basilixiab group	Basiliximab	Age and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group)
Basilixiab group	Kidney transplantation	Age and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group)

Primary Outcome Measures

Name	Time	Method
Incidence of rejection	within 3 years	The investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy.

Secondary Outcome Measures

Name	Time	Method
Incidence of infection	postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years	The investigators measures incidence of infection such as CMV, BKV infection, pneumonia, urinary tract infection and other infections.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of