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NCT Number: NCT07436338

ABO- or HLA- Incompatible LDKT Compared to Waitlist/DDKT in Elderly Patients

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University College of Medicine, Seoul, Jongno-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Severance Hospital

Registry information

Official study title

Survival Benefit of ABO- or HLA- Incompatible Living Donor Kidney Transplantation in the Elderly.

Important dates

Study start
2010
Primary completion
2023
Study completion
2024
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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