Kidney TransplantNCT07436338
ABO- or HLA- Incompatible LDKT Compared to Waitlist/DDKT in Elderly Patients
An observational study of Kidney Transplant and End Stage Kidney Disease (ESRD), run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This retrospective multicenter cohort study evaluates the survival outcomes of elderly patients (aged ≥60 years) with end-stage kidney disease who underwent ABO- or HLA-incompatible living donor kidney transplantation compared with those managed with a conventional waitlisting strategy, including deceased donor kidney… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Kidney Transplant, End Stage Kidney Disease (ESRD)
- How many people
- 1,819 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Oct 2010to 31 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study population was derived from elderly patients registered on the kidney transplant waiting lists at two tertiary referral transplant centers in South Korea (Severance Hospital and Seoul National University Hospital). Participants were identified from institutional transplant databases, and deidentified clinical data were retrospectively collected and analyzed.
Who may be able to join
- Age 60 years or older
- Diagnosis of end-stage kidney disease (ESKD) requiring maintenance dialysis
- Registered on the kidney transplant waiting list between November 2010 and December 2023
Who cannot join
- Complement-dependent cytotoxicity crossmatch positive
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University College of Medicine
Seoul, Jongno-gu, 03080
Yonsei University College of Medicine
Seoul, Seodaemun-gu, 03722
About this study
Official title: Survival Benefit of ABO- or HLA- Incompatible Living Donor Kidney Transplantation in the Elderly.
This retrospective multicenter cohort study evaluates the survival outcomes of elderly patients (aged ≥60 years) with end-stage kidney disease who underwent ABO- or HLA-incompatible living donor kidney transplantation compared with those managed with a conventional waitlisting strategy, including deceased donor kidney transplantation or remaining on the waiting list.
Elderly patients often experience prolonged waiting times for deceased donor transplantation, during which dialysis-related complications may increase the risk of morbidity and mortality. Desensitization protocols have enabled transplantation across immunologic barriers, such as ABO or HLA incompatibility, potentially allowing earlier access to transplantation.
Using data from two Korean transplant centers, this study compares overall survival and transplant-related outcomes between patients undergoing desensitized living donor transplantation and those managed with a waitlist-initiated strategy. The objective is to determine whether desensitized living donor kidney transplantation provides a survival advantage and represents a safe and effective treatment option for elderly patients.
Read the detailed description
This retrospective multicenter cohort study was conducted at Severance Hospital and Seoul National University Hospital between November 2010 and December 2023. The study included patients aged 60 years or older who initiated dialysis and were registered on the kidney transplant waiting list.
Patients were categorized into two groups:
The desensitized living donor kidney transplantation (LDKT) group, which included recipients of ABO-incompatible (ABOi), HLA-incompatible (HLAi), or combined ABOi/HLAi transplantation following desensitization therapy.
The conventional waitlisting strategy (CWS) group, defined as patients managed with a standard waitlisting approach who either underwent deceased donor kidney transplantation (DDKT) during follow-up or remained on the waiting list.
Immunologic assessment included ABO blood typing, isoagglutinin titers, flow cytometry crossmatch testing, and detection of donor-specific antibodies using single-antigen bead assays. Desensitization protocols consisted of rituximab administration, plasmapheresis with or without intravenous immunoglobulin, and risk-adapted induction therapy using basiliximab or anti-thymocyte globulin. Maintenance immunosuppression included tacrolimus, mycophenolate mofetil, and corticosteroids.
To minimize selection bias, propensity score matching was performed to balance baseline characteristics between groups. Time-dependent Cox proportional hazards models were applied to account for immortal time bias related to pretransplant waiting periods. Transplantation (LDKT or DDKT) was treated as a time-dependent exposure in survival analyses.
The primary outcome was overall patient survival. Secondary outcomes included graft survival and biopsy-proven acute rejection. Subgroup analyses were performed according to immunologic incompatibility (ABOi only, HLAi only, or combined ABOi/HLAi).
This study aims to determine whether desensitized living donor kidney transplantation provides a survival benefit compared with a conventional waitlisting strategy in elderly patients with end-stage kidney disease.
- Conditions
- Kidney Transplant, End Stage Kidney Disease (ESRD)
- Keywords
- Desensitized Living donor kidney transplantation, elderly patient, waitlist mortality, survival outcomes
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Patients on Kidney Transplant Waiting List | Patients aged 60 years or older registered on the kidney transplant waiting list, including those who underwent desensitized living donor kidney transplantation or were managed with a conventional waitlisting strategy, defined as receiving deceased donor kidney transplantation or remaining on the waitlist during follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Patient survival was defined as the time from dialysis initiation to death from any cause. Patients were censored at the date of last follow-up if alive. Survival probabilities were estimated using the Kaplan-Meier method and compared between groups using time-dependent Cox proportional hazards models to account for transplantation as a time-dependent exposure.
Measured: From dialysis initiation up to 10 years of follow-up
Secondary outcomes (1)
5-Year Graft Survival
Graft survival was defined as the time from kidney transplantation to graft failure. Graft failure was defined as return to maintenance dialysis, re-transplantation, or death with a functioning graft. Participants without graft failure were censored at the date of last follow-up. Survival probabilities were estimated using the Kaplan-Meier method and compared between groups using Cox proportional hazards models.
Measured: Up to 5 years after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Oct 2010
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- 1,819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital
- Responsible party
- Principal investigator, Sang-Il Min, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436338
- Sponsor's protocol ID
- SNUH_Sev_desensitized LDKT
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that are de-identified will be made available upon reasonable request to the corresponding author, subject to institutional review board approval and execution of a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Benefit of ABO- or HLA- Incompatible Living Donor Kidney Transplantation in the Elderly.
- ClinicalTrials.gov ID
- NCT07436338
- Acronym / sponsor ID
- SNUH_Sev_desensitized LDKT
- Conditions
- Kidney Transplant, End Stage Kidney Disease (ESRD)
- Keywords
- Desensitized Living donor kidney transplantation, elderly patient, waitlist mortality, survival outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,819 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Feb 2026 (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.
This retrospective multicenter cohort study evaluates the survival outcomes of elderly patients (aged ≥60 years) with end-stage kidney disease who underwent ABO- or HLA-incompatible living donor kidney transplantation compared with those managed with a conventional waitlisting strategy, including deceased donor kidney transplantation or remaining on the waiting list.
Elderly patients often experience prolonged waiting times for deceased donor transplantation, during which dialysis-related complications may increase the risk of morbidity and mortality. Desensitization protocols have enabled transplantation across immunologic barriers, such as ABO or HLA incompatibility, potentially allowing earlier access to transplantation.
Using data from two Korean transplant centers, this study compares overall survival and transplant-related outcomes between patients undergoing desensitized living donor transplantation and those managed with a waitlist-initiated strategy. The objective is to determine whether desensitized living donor kidney transplantation provides a survival advantage and represents a safe and effective treatment option for elderly patients.
Detailed description
This retrospective multicenter cohort study was conducted at Severance Hospital and Seoul National University Hospital between November 2010 and December 2023. The study included patients aged 60 years or older who initiated dialysis and were registered on the kidney transplant waiting list.
Patients were categorized into two groups:
The desensitized living donor kidney transplantation (LDKT) group, which included recipients of ABO-incompatible (ABOi), HLA-incompatible (HLAi), or combined ABOi/HLAi transplantation following desensitization therapy.
The conventional waitlisting strategy (CWS) group, defined as patients managed with a standard waitlisting approach who either underwent deceased donor kidney transplantation (DDKT) during follow-up or remained on the waiting list.
Immunologic assessment included ABO blood typing, isoagglutinin titers, flow cytometry crossmatch testing, and detection of donor-specific antibodies using single-antigen bead assays. Desensitization protocols consisted of rituximab administration, plasmapheresis with or without intravenous immunoglobulin, and risk-adapted induction therapy using basiliximab or anti-thymocyte globulin. Maintenance immunosuppression included tacrolimus, mycophenolate mofetil, and corticosteroids.
To minimize selection bias, propensity score matching was performed to balance baseline characteristics between groups. Time-dependent Cox proportional hazards models were applied to account for immortal time bias related to pretransplant waiting periods. Transplantation (LDKT or DDKT) was treated as a time-dependent exposure in survival analyses.
The primary outcome was overall patient survival. Secondary outcomes included graft survival and biopsy-proven acute rejection. Subgroup analyses were performed according to immunologic incompatibility (ABOi only, HLAi only, or combined ABOi/HLAi).
This study aims to determine whether desensitized living donor kidney transplantation provides a survival benefit compared with a conventional waitlisting strategy in elderly patients with end-stage kidney disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Patients on Kidney Transplant Waiting List | – | –Patients aged 60 years or older registered on the kidney transplant waiting list, including those who underwent desensitized living donor kidney transplantation or were managed with a conventional waitlisting strategy, defined as receiving deceased donor kidney transplantation or remaining on the waitlist during follow-up. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study population was derived from elderly patients registered on the kidney transplant waiting lists at two tertiary referral transplant centers in South Korea (Severance Hospital and Seoul National University Hospital). Participants were identified from institutional transplant databases, and deidentified clinical data were retrospectively collected and analyzed.
Key inclusion criteria (3 listed)
- Age 60 years or older
- Diagnosis of end-stage kidney disease (ESKD) requiring maintenance dialysis
- Registered on the kidney transplant waiting list between November 2010 and December 2023
Key exclusion criteria (1 listed)
- Complement-dependent cytotoxicity crossmatch positive
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
Patient survival
Time frame: From dialysis initiation up to 10 years of follow-up
Patient survival was defined as the time from dialysis initiation to death from any cause. Patients were censored at the date of last follow-up if alive. Survival probabilities were estimated using the Kaplan-Meier method and compared between groups using time-dependent Cox proportional hazards models to account for transplantation as a time-dependent exposure.
1 secondary outcome
5-Year Graft Survival
Time frame: Up to 5 years after kidney transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that are de-identified will be made available upon reasonable request to the corresponding author, subject to institutional review board approval and execution of a data use agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 and End Stage Kidney Disease (ESRD), run by Seoul National University Hospital at 2 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: From dialysis initiation up to 10 years of follow-up). 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 27 Feb 2026.