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Completed

NCT Number: NCT06016283

Sex Impact on Long-term Outcomes of LDKT

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.

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Key information

Conditions

Kidney Transplant Failure and Rejection Behavior Coitus Gender Rejection, Psychology Sexual Behavior Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yitian Fang

Rotterdam, South Holland, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Death-censored graft survival

    Time frame: 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 outcomes

  1. Patient survival

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

The Impact of Donor and Recipient Sex on Long-term Outcomes Following Living Donor Kidney Transplantation

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2023
Registry last updated
Dec 5, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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