- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02459977
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 Contact
- Name: Chung Hee Baek, M.D.
- Phone Number: 82-2-3010-1481
- Email: bch393@naver.com
Study Contact Backup
- Name: Su-Kil Park, M.D, PhD
- Phone Number: 82-2-3010-3263
Study Locations
-
-
-
Seoul, Korea, Republic of, 138-736
- Recruiting
- Asan Medical Center
-
Contact:
- Su-Kil Park, M.D., PhD
- Phone Number: 82-2-3010-3263
- Email: skpark@amc.seoul.kr
-
Contact:
- Chung Hee Baek, M.D.
- Phone Number: 82-2-3010-1481
- Email: bch393@naver.com
-
-
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
16 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.
|
No basiliximab induction therapy
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)
|
kidney transplantation
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
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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