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

NCT07436338 | Completed

• 1 other identifier: SNUH_Sev_desensitized LDKT
• Study Type: observational
• Target: 1,819
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Kidney Transplant; End Stage Kidney Disease (ESRD)

Keywords

Desensitized Living donor kidney transplantation; elderly patient; waitlist mortality; survival outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  From dialysis initiation up to 10 years of follow-up

Secondary Outcomes (1)

• 5-Year Graft Survival

  Up to 5 years after kidney transplantation

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Complement-dependent cytotoxicity crossmatch positive

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Severance Hospital: collaborator

Study Sites (2)

Seoul National University College of Medicine

Seoul, Jongno-gu, 03080, South Korea

Location

Yonsei University College of Medicine

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: October 1, 2010
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Individual participant data and supporting documents will be available beginning 6 months after publication of the primary results and will remain available for 5 years following publication.
• Access Criteria: Access to deidentified individual participant data, study protocol, statistical analysis plan, and analytic code will be granted to researchers who provide a methodologically sound research proposal. Requests will be subject to institutional review board approval and execution of a data use agreement. Data will be shared through secure data transfer upon approval by the corresponding author and participating institutions.

Locations

KR (2)