Kidney Transplant RejectionNCT06348446
Tacrolimus Exposure in Kidney Transplantation
An observational study of Kidney Transplant Rejection, run by Seoul National University Hospital at 4 sites in South Korea.
Trial summary
Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant Rejection
- How many people
- 12,000 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Feb 2022to 30 Aug 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers are included. Further selection will be undertaken to include only patients receiving oral tacrolimus as one of the main immunosuppressant at post-transplant 2 month (for early outcomes) and post-transplant 1 year (for late outcomes).
Who may be able to join
- Renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers
- Patients receiving oral tacrolimus as one of the main immunosuppressant at the start of the defined cohort time (i.e. at post-transplant 2 months for the analysis of 1-year outcomes and at post-transplant 12 months for the analysis of 6-year outcomes)
Who cannot join
- Graft failure occurring within the first 2 month of transplantation
- Mortality of any cause occurring within the first 2 month of transplantation
- Patients moving centers during the study period
- Patients who have received other organ transplantation(s) besides renal transplantation in the defined period
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Asan medical center, Seoul, Korea
Seoul
Young Hoon Kim, MD, 82-10-2705-6998, kyh-001@hanmail.net
- Recruiting
Samsung medical center, Seoul, Korea
Seoul
Jae Berm Park, MD, 82-10-8971-1953, jbparkmd@gmail.com
- Recruiting
Seoul St. Mary's hospital, Seoul, Korea
Seoul
Sun Cheol Park, MD, 82-10-6310-2847, sun60278@catholic.ac.kr
- Recruiting
Severance hospital, Seoul, Korea
Seoul
kyuha Hur, MD, 82-10-2043-9947, KHHUH@yuhs.ac
About this study
Official title: Tacrolimus Exposure and Outcomes in Kidney Transplant Patients: A Retrospective Multicenter Study of Clinical Data Warehouse (CDW) in South Korea
Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation.
- Conditions
- Kidney Transplant Rejection
- Keywords
- kidney transplantation, tacrolimus, acute rejection, graft survival, adverse event
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes
the relationship between time varying periodic mean of tacrolimus trough level during 2-12 mo. post-transplant and a composite of 1-year allograft outcomes consisting of biopsy proven acute rejection, renal dysfunction (eGFR<30), development of dnDSA, and death censored graft failure that occurred within 1 year from the latest transplant.
Measured: 1 year after transplantation
Secondary outcomes (4)
relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome
the relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome that occurred within 6 years from the latest transplant
Measured: 6 year after transplantation
relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection
the relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection (1-year and 6-year)
Measured: 6 year after transplantation
relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event
the relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event (1-year and 6-year)
Measured: 6 year after transplantation
relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality
the relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality (1-year and 6-year)
Measured: 6 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Feb 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348446
- Sponsor's protocol ID
- FY20-2963
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus Exposure and Outcomes in Kidney Transplant Patients: A Retrospective Multicenter Study of Clinical Data Warehouse (CDW) in South Korea
- ClinicalTrials.gov ID
- NCT06348446
- Acronym / sponsor ID
- FY20-2963
- Conditions
- Kidney Transplant Rejection
- Keywords
- kidney transplantation, tacrolimus, acute rejection, graft survival, adverse event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 4 Apr 2024 (actual)
- 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.
Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers are included. Further selection will be undertaken to include only patients receiving oral tacrolimus as one of the main immunosuppressant at post-transplant 2 month (for early outcomes) and post-transplant 1 year (for late outcomes).
Key inclusion criteria (2 listed)
- Renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers
- Patients receiving oral tacrolimus as one of the main immunosuppressant at the start of the defined cohort time (i.e. at post-transplant 2 months for the analysis of 1-year outcomes and at post-transplant 12 months for the analysis of 6-year outcomes)
Key exclusion criteria (4 listed)
- Graft failure occurring within the first 2 month of transplantation
- Mortality of any cause occurring within the first 2 month of transplantation
- Patients moving centers during the study period
- Patients who have received other organ transplantation(s) besides renal transplantation in the defined period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes
Time frame: 1 year after transplantation
the relationship between time varying periodic mean of tacrolimus trough level during 2-12 mo. post-transplant and a composite of 1-year allograft outcomes consisting of biopsy proven acute rejection, renal dysfunction (eGFR<30), development of dnDSA, and death censored graft failure that occurred within 1 year from the latest transplant.
4 secondary outcomes
relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome
Time frame: 6 year after transplantation
relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection
Time frame: 6 year after transplantation
relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event
Time frame: 6 year after transplantation
relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality
Time frame: 6 year after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplant Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
Active, not recruiting
Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
Renal Transplantation
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingPhase 1
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Kidney Transplant Rejection
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by Seoul National University Hospital at 4 sites 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 2 inclusion and 4 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Sangil Min (01071739341, surgeonmsi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes (time frame: 1 year after transplantation). 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 4 Apr 2024.