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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02459977
Enrollment
40
Registered
2015-06-02
Start date
2012-04-30
Completion date
Unknown
Last updated
2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

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).

Interventions

DRUGBasiliximab

Basiliximab induction therapy

DRUGNo basiliximab

No basiliximab induction therapy

PROCEDUREKidney transplantation

kidney transplantation

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of rejectionwithin 3 yearsThe investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy.

Secondary

MeasureTime frameDescription
Incidence of infectionpostoperative 6 month, 1 year, 1.5 year, 2 years and 3 yearsThe investigators measures incidence of infection such as CMV, BKV infection, pneumonia, urinary tract infection and other infections.

Countries

South Korea

Contacts

Primary ContactChung Hee Baek, M.D.
bch393@naver.com82-2-3010-1481
Backup ContactSu-Kil Park, M.D, PhD
82-2-3010-3263

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026