- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436338
ABO- or HLA- Incompatible LDKT Compared to Waitlist/DDKT in Elderly Patients
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jongno-gu
-
Seoul, Jongno-gu, South Korea, 03080
- Seoul National University College of Medicine
-
-
Seodaemun-gu
-
Seoul, Seodaemun-gu, South Korea, 03722
- Yonsei University College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Complement-dependent cytotoxicity crossmatch positive
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From dialysis initiation up to 10 years of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5-Year Graft Survival
Time Frame: Up to 5 years after kidney transplantation
|
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.
|
Up to 5 years after kidney transplantation
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- SNUH_Sev_desensitized LDKT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Kidney Transplant
-
University of ManchesterManchester University NHS Foundation TrustNot yet recruitingKidney Transplant | Kidney Transplant Recipient | Kidney Transplant DonorUnited Kingdom
-
University of MinnesotaWithdrawnKidney Transplant Rejection | Kidney Transplant; Complications | Kidney Transplant FailureUnited States
-
The University of Texas Medical Branch, GalvestonNational Institute of Allergy and Infectious Diseases (NIAID)Active, not recruitingKidney Transplant Rejection | Kidney TransplantUnited States
-
Universitaire Ziekenhuizen KU LeuvenActive, not recruitingKidney Transplantation | Kidney Transplant Rejection | Kidney Transplant FailureBelgium
-
University of GuadalajaraInstituto Mexicano del Seguro SocialActive, not recruitingKidney Transplant Failure | Kidney TransplantMexico
-
University of MinnesotaCompletedKidney Transplant Rejection | Kidney Transplant; Complications | Transplant; Complication, Rejection | Kidney Transplant Failure and Rejection | Transplant DysfunctionUnited States
-
Ohio State UniversityCompletedKidney Transplant; Complications | Kidney TransplantUnited States
-
Providence Health & ServicesWashington State University; Paul I Terasaki Foundation LaboratoryUnknownKidney Transplant | Kidney/Pancreas TransplantUnited States
-
Hospital de Clinicas de Porto AlegreActive, not recruitingKidney Transplant Infection | Kidney Transplant Rejection | Kidney Transplant Failure | Kidney Transplant Failure and RejectionBrazil
-
University of LiegeRecruitingKidney Transplant Rejection | Kidney Transplant; ComplicationsBelgium