Kidney TransplantationNCT02459977
The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea
A study testing Basiliximab, No basiliximab and Kidney transplantation in people with Kidney Transplantation, run by Asan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Basiliximab, No basiliximab and Kidney transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ABO compatible and T-flow negative transplants
- Living kidney transplantation
- Tacrolimus based immunosuppression
Who cannot join
- Multiorgan transplantation
- Zero-mismatch transplantation (we use cyclosporine instead of FK506)
Trial locations and contacts
1 site in 1 country.
Su-Kil Park, M.D, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Su-Kil Park, M.D., PhD, 82-2-3010-3263, skpark@amc.seoul.kr
Chung Hee Baek, M.D., 82-2-3010-1481, bch393@naver.com
About this study
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.
Read the 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).
- Conditions
- Kidney Transplantation
- Being tested
- Basiliximab, No basiliximab, Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
Basiliximab induction therapy
No basiliximabDrug
No basiliximab induction therapy
Kidney transplantationProcedure or surgery
kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| No basiliximab group | Experimental | The investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants. Receives: Drug: No basiliximab; Procedure: Kidney transplantation |
| Basilixiab group | Active comparator | Age and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group) Receives: Drug: Basiliximab; Procedure: Kidney transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of rejection
The investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy.
Measured: within 3 years
Secondary outcomes (1)
Incidence of infection
The investigators measures incidence of infection such as CMV, BKV infection, pneumonia, urinary tract infection and other infections.
Measured: postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startApr 2012
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-Kil Park, Asan Medical Center
- Investigators
- Su-Kil Park, M.D, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459977
- Sponsor's protocol ID
- 2013-0209
- Status last verified
- May 2015
- First submitted
- 28 Apr 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea
- ClinicalTrials.gov ID
- NCT02459977
- Acronym / sponsor ID
- 2013-0209
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (estimated)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No basiliximab group | Experimental | Drug: No basiliximab, Procedure: Kidney transplantationThe investigators omit basiliximab induction therapy in one to three-HLA mismatched living donor renal transplants. |
| Basilixiab group | Active comparator | Drug: Basiliximab, Procedure: Kidney transplantationAge and sex matched patients who underwent one to three-HLA mismatched living donor renal transplants with basiliximab induction therapy (Control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ABO compatible and T-flow negative transplants
- Living kidney transplantation
- Tacrolimus based immunosuppression
Key exclusion criteria (2 listed)
- Multiorgan transplantation
- Zero-mismatch transplantation (we use cyclosporine instead of FK506)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BasiliximabBasiliximab induction therapy | Drug | Basilixiab group |
| No basiliximabNo basiliximab induction therapy | Drug | No basiliximab group |
| Kidney transplantationkidney transplantation | Procedure or surgery | Basilixiab group, No basiliximab group |
Primary outcome
Incidence of rejection
Time frame: within 3 years
The investigators measures incidence of rejection by serum creatinine, urinalysis and kidney allograft biopsy.
1 secondary outcome
Incidence of infection
Time frame: postoperative 6 month, 1 year, 1.5 year, 2 years and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su-Kil Park, M.D, PhD contact
Su-Kil Park, M.D, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basiliximab, No basiliximab and Kidney transplantation in people with Kidney Transplantation, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung Hee Baek, M.D. (82-2-3010-1481, bch393@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of rejection (time frame: within 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.