Clinical trial NCT06016283: Sex Impact on Long-term Outcomes of LDKT
Official title: The Impact of Donor and Recipient Sex on Long-term Outcomes Following Living Donor Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Failure and Rejection
Gender
Keywords: gender
kidney transplantation
minor histocompatibility
graft survival
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2023-08-29
Enrollment: 1276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death-censored graft survival
timeFrame: 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.
Secondary outcomes:
measure: Patient survival
timeFrame: 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.
measure: DGF
timeFrame: From the date of kidney transplantation till the end of first posttransplant week, assessed up to one week.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Yitian Fang
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Robert Minnee, PhD
role: PRINCIPAL_INVESTIGATOR
References: