The Impact of Gender on Graft Outcomes Following Living Donor Kidney Transplantation

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT06016283
Collaborator
(none)
1,276
1
14.9
85.4

Study Details

Study Description

Brief Summary

The impact of donor and recipient gender combination on kidney transplant outcomes has been reported in several studies. The results vary greatly due to different factors, such as minor histocompatibility antigens, nephron overload, sex hormones, etc. Despite advancements in clinical practice, no large-scale studies exploring this question in living donor kidney transplantation have been conducted in the subsequent two decades. Our study aims to address this research gap and provide updated information on outcomes in relation to the gender combination following living donor kidney transplantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The impact of donor and recipient gender combination on kidney transplant outcomes has been reported in several studies, but with inconclusive results. From an immunologic perspective, the transplantation of male donor kidneys into female recipients was associated with an increased risk of graft failure and mortality due to H-Y minor histocompatibility antigens. Another theory, based on nephron overload and hyperfiltration, suggests that male recipients of female donor kidneys tend to experience worse outcomes due to the smaller size of female kidneys. Additionally, the influence of sex hormones has been explored. Aufhauser et al. found that estrogen acts as a protective factor against ischemia-reperfusion injury (IRI), resulting in a significantly lower incidence of delayed graft function (DGF) in female recipients compared to male recipients. These findings seem conflicting, and most of studies have primarily focused on deceased donor kidney transplantation.

    In addition, Kayler et al. analyzed a transplant database encompassing 30,258 living donor kidney transplantations between 1990 and 1999. Their study revealed a significant advantage in graft survival for male recipients of male donor kidneys compared to the other combinations. Another study involving 5,716 HLA-identical sibling kidney transplantations between 1985 and 2000 demonstrated that female recipients tend to have better graft survival rates regardless of the donor's gender. Despite advancements in clinical practice, no such large-scale studies exploring this question have been conducted in the subsequent two decades. Our study aims to address this research gap and provide updated information on outcomes in relation to the gender combination following living donor kidney transplantation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1276 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Impact of Donor and Recipient Gender on Long-term Outcomes Following Living Donor
    Actual Study Start Date :
    Apr 1, 2022
    Actual Primary Completion Date :
    Apr 1, 2023
    Actual Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    MDMR

    Male recipient receiving kidney graft from male donor

    FDMR

    Male recipient receiving kidney graft from female donor

    MDFR

    Female recipient receiving kidney graft from male donor

    FDFR

    Female recipient receiving kidney graft from female donor

    Outcome Measures

    Primary Outcome Measures

    1. Death-censored graft survival [From the date of kidney transplantation until the date of graft loss from any cause or the end of follow-up, whichever came first, assessed up to 10 years.]

      Graft failure is defined as return to dialysis, transplant nephrectomy or retransplant. Death-censored graft failure was defined as the time from transplant to graft failure, with censoring for death with a functioning graft.

    Secondary Outcome Measures

    1. Patient survival [From the date of kidney transplantation until the date of death from any cause or the end of follow-up, whichever came first, assessed up to 10 years.]

      All-cause mortality is included in the patient survival.

    2. DGF [From the date of kidney transplantation till the end of first posttransplant week, assessed up to one week.]

      Delayed graft function (DGF) is defined as either the need for dialysis or the failure of a fall in serum creatinine of 10% on three consecutive days in the first posttransplant week.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
    Exclusion Criteria:
    • Recipients who were under 18 years at transplant or had no follow-up.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yitian Fang Rotterdam Zuid Holland Netherlands 3015 GD

    Sponsors and Collaborators

    • Erasmus Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yitian Fang, MD, MD, Erasmus Medical Center
    ClinicalTrials.gov Identifier:
    NCT06016283
    Other Study ID Numbers:
    • NT Gender
    First Posted:
    Aug 29, 2023
    Last Update Posted:
    Aug 29, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yitian Fang, MD, MD, Erasmus Medical Center

    Study Results

    No Results Posted as of Aug 29, 2023