Sex Impact on Long-term Outcomes of LDKT

NCT06016283 | Completed

• 1 other identifier: Sex impact on LDKT
• Study Type: observational
• Target: 1,276
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Failure and Rejection; Gender

Keywords

gender; kidney transplantation; minor histocompatibility; graft survival

Outcome Measures

Primary Outcomes (1)

• Death-censored graft survival

  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 Outcomes (2)

• 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

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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on biological gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Recipients who were under 18 years at transplant or had no follow-up.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Yitian Fang

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Rejection, Psychology; Coitus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Sexual Behavior

Study Officials

• Robert Minnee, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 29, 2023
• Study Start: April 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)