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

NCT ID: NCT02459977

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No basiliximab group

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

Group Type EXPERIMENTAL

No basiliximab

Intervention Type DRUG

No basiliximab induction therapy

Kidney transplantation

Intervention Type PROCEDURE

kidney transplantation

Basilixiab group

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

Group Type ACTIVE_COMPARATOR

Basiliximab

Intervention Type DRUG

Basiliximab induction therapy

Kidney transplantation

Intervention Type PROCEDURE

kidney transplantation

Interventions

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Basiliximab

Basiliximab induction therapy

Intervention Type DRUG

No basiliximab

No basiliximab induction therapy

Intervention Type DRUG

Kidney transplantation

kidney transplantation

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Su-Kil Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Su-Kil Park, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chung Hee Baek, M.D.

Role: CONTACT

82-2-3010-1481

Su-Kil Park, M.D, PhD

Role: CONTACT

82-2-3010-3263

Facility Contacts

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Su-Kil Park, M.D., PhD

Role: primary

82-2-3010-3263

Chung Hee Baek, M.D.

Role: backup

82-2-3010-1481

Other Identifiers

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2013-0209

Identifier Type: -

Identifier Source: org_study_id

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