Kidney Transplant Failure and RejectionNCT06016283
Sex Impact on Long-term Outcomes of LDKT
An observational study of Kidney Transplant Failure and Rejection and Gender, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure and Rejection, Gender
- How many people
- 1,276 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2022to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
Who may be able to join
- Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
Who cannot join
- Recipients who were under 18 years at transplant or had no follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Donor and Recipient Sex on Long-term Outcomes Following Living Donor Kidney Transplantation
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.
Read the 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.
- Conditions
- Kidney Transplant Failure and Rejection, Gender
- Keywords
- gender, kidney transplantation, minor histocompatibility, graft survival
- Medical subject headings
- Rejection, Psychology, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
All-cause mortality is included in the patient survival.
Measured: 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
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.
Measured: From the date of kidney transplantation till the end of first posttransplant week, assessed up to one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Apr 2022
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Yitian Fang, MD, Erasmus Medical Center
- Investigators
- Robert Minnee, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016283
- Sponsor's protocol ID
- Sex impact on LDKT
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Donor and Recipient Sex on Long-term Outcomes Following Living Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06016283
- Acronym / sponsor ID
- Sex impact on LDKT
- Conditions
- Kidney Transplant Failure and Rejection, Gender
- Keywords
- gender, kidney transplantation, minor histocompatibility, graft survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,276 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
Key inclusion criteria (1 listed)
- Patients undergoing living donor kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
Key exclusion criteria (1 listed)
- Recipients who were under 18 years at transplant or had no follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
DGF
Time frame: From the date of kidney transplantation till the end of first posttransplant week, assessed up to one week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Minnee, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure and Rejection and Gender, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.