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

May 29, 2015 updated by: Su-Kil Park, Asan Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of rejection
Time Frame: within 3 years
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
Time Frame: 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.
postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Su-Kil Park, M.D, PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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