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

Asan Medical Center

Status: Unknown

Conditions: Kidney Transplantation

Treatments: Procedure: Kidney transplantation; Drug: No basiliximab; Drug: Basiliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02459977

2013-0209

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

No basiliximab group

Experimental group

Description:

The investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants.

Treatment:

Procedure: Kidney transplantation

Drug: No basiliximab

Basilixiab group

Active Comparator group

Description:

Age and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group)

Treatment:

Procedure: Kidney transplantation

Drug: Basiliximab