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NCT02459977 Clinical Trial

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

Kidney Transplantation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02459977
Other study ID # 2013-0209
Secondary ID
Status Recruiting
Phase N/A
First received April 28, 2015
Last updated May 29, 2015
Start date April 2012

Study information
Verified date May 2015
Source Asan Medical Center
Contact Chung Hee Baek, M.D.
Phone 82-2-3010-1481
Email bch393@naver.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Basiliximab
Basiliximab induction therapy
• No basiliximab
No basiliximab induction therapy
Procedure:
• Kidney transplantation
kidney transplantation

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of rejection The investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy. within 3 years No
Secondary Incidence of infection 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 No
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