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

August 25, 2023 updated by: Yitian Fang, MD, Erasmus Medical Center

The Impact of Donor and Recipient Gender on Long-term Outcomes Following Living Donor

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3015 GD
        • Yitian Fang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
From the date of kidney transplantation till the end of first posttransplant week, assessed up to one week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NT Gender

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support this study are not publicly available due to the reasons of sensitivity and are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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