Kidney Transplant DonorNCT07793877
Modifiable Factors Affecting Racial Disparities in Kidney Donation
An observational study of Kidney Transplant Donor, run by The Methodist Hospital Research Institute.
Trial summary
While many people offer to be evaluated at transplant centers as potential living donors to donate one kidney to someone they know, few ultimately donate. Racial/ethnic minorities are less likely to become living donors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant Donor
- What is being tested?
- Not applicable- observational study
- How many people
- 2,332 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2022to 30 Nov 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: "Donor volunteers" defined as persons who contacted SBMC or UCLA to request an information packet regarding live kidney donation and then completed and returned a Living Donor Referral Form (included in the packet). Persons who received an information packet but failed to return the Living Donor Referral Form were not considered donor volunteers and were not eligible for the cohort study.
Who may be able to join
- Live kidney donor volunteer
Who cannot join
- Limited proficiency in both English and Spanish
- Required assistance to fill out the study questionnaire
- Non-directed donors (altruistic donors who lack a specific intended recipient)
- Failure to complete baseline questionnaire
About this study
Official title: Modifiable Factors Affecting Live Donor Disparities (MFALDD) - Living Donors Secondary Analysis
While many people offer to be evaluated at transplant centers as potential living donors to donate one kidney to someone they know, few ultimately donate. Racial/ethnic minorities are less likely to become living donors. This study examines potentially modifiable factors affecting living donation in a large cohort of potential living donors from different transplant centers who are White, Black, Hispanic, and Asian. Investigators are examining ways to intervene with potential living donors to help overcome racial disparities and increase the number of people who ultimately donate.
Read the detailed description
The donor data collected for use in this protocol was completed from 2014 to 2018 at an outside institution. 2332 donor volunteers were evaluated at that time and all data was deidentified and brought by the principal investigator to HMRI for secondary data analysis. Five study aims were highlighted in the research strategy.
The first three aims in the original research strategy/protocol WILL NOT be included in this study because this study covers the secondary data analysis ONLY. The emphasis of this study are the last two aims (#4 and #5 of the original research strategy/protocol).
- Conditions
- Kidney Transplant Donor
- Being tested
- Not applicable- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Potential living donors who presented for evaluation at 5 transplant centers were invited to participate in an exploratory study assessing their motivations for donating, their living donation knowledge, their financial barriers to donating, and their educational preparedness. All potential living donors completed Survey 1, and a subset of individuals who completed living donor evaluation, completed Survey 2. After 12 months, chart review for all individuals who completed Survey 1 occurred to determine whether they received a transplant or not, and if not what reasons they were ruled out. No data collection took place at Houston Methodist.
| Study group | Role | What they receive |
|---|---|---|
| Living Donor Volunteers | Individuals interested in donating a live kidney Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
How Changeable Factors Affect Completion of Living Donor Evaluation for Black, Hispanic, and White Volunteers
Metrics of interest include whether donor volunteers present for evaluation, defined as attending the first in-person visit, and whether they complete the donor evaluation, defined as finishing all required steps except donation. Both outcomes are measured as yes or no. Investigators will use logistic regression to examine differences in the likelihood of presentation and completion among Black, Hispanic, and White donors. Initial analyses will examine the relationship between race and each outcome separately. Race will then be included in multivariable models, with survey-based factors added by category. Changes in the size or significance of race effects after adjustment will be evaluated. If the association between race and evaluation outcomes is reduced after accounting for specific modifiable factors, these factors may represent potential targets for future interventions.
Measured: From onset of evaluation to the outcomes at 12 months
Secondary outcomes (1)
How Changeable Factors Influence Whether Living Donors Go on to Donate, Including Through Paired Exchange
Investigators will compare the odds of donating a kidney directly or through paired exchange among Black, Hispanic, and White donor volunteers using logistic regression models. Model fit will be assessed as previously described. As in the primary measure, the bivariate relationship between donor race and each outcome will first be examined using simple logistic regression. Race will then be forced into successive models, with survey variables entered simultaneously by category. Investigators will track whether the magnitude (odds ratio) or significance of the race effect changes as additional factors are included.
Measured: From the onset of evaluation until the date of first documented live kidney donation, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start4 Feb 2022
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant DonorStudies of the same condition, open and under way.
- 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
- 2,332 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793877
- Sponsor's protocol ID
- PRO00033546
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifiable Factors Affecting Live Donor Disparities (MFALDD) - Living Donors Secondary Analysis
- ClinicalTrials.gov ID
- NCT07793877
- Acronym / sponsor ID
- PRO00033546
- Conditions
- Kidney Transplant Donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,332 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 31 Aug 2026 (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.
While many people offer to be evaluated at transplant centers as potential living donors to donate one kidney to someone they know, few ultimately donate. Racial/ethnic minorities are less likely to become living donors. This study examines potentially modifiable factors affecting living donation in a large cohort of potential living donors from different transplant centers who are White, Black, Hispanic, and Asian. Investigators are examining ways to intervene with potential living donors to help overcome racial disparities and increase the number of people who ultimately donate.
Detailed description
The donor data collected for use in this protocol was completed from 2014 to 2018 at an outside institution. 2332 donor volunteers were evaluated at that time and all data was deidentified and brought by the principal investigator to HMRI for secondary data analysis. Five study aims were highlighted in the research strategy.
The first three aims in the original research strategy/protocol WILL NOT be included in this study because this study covers the secondary data analysis ONLY. The emphasis of this study are the last two aims (#4 and #5 of the original research strategy/protocol).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living Donor Volunteers | – | Other: Not applicable- observational studyIndividuals interested in donating a live kidney |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- "Donor volunteers" defined as persons who contacted SBMC or UCLA to request an information packet regarding live kidney donation and then completed and returned a Living Donor Referral Form (included in the packet). Persons who received an information packet but failed to return the Living Donor Referral Form were not considered donor volunteers and were not eligible for the cohort study.
Key inclusion criteria (1 listed)
- Live kidney donor volunteer
Key exclusion criteria (4 listed)
- Limited proficiency in both English and Spanish
- Required assistance to fill out the study questionnaire
- Non-directed donors (altruistic donors who lack a specific intended recipient)
- Failure to complete baseline questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyPotential living donors who presented for evaluation at 5 transplant centers were invited to participate in an exploratory study assessing their motivations for donating, their living donation knowledge, their financial barriers to donating, and their educational preparedness. All potential living donors completed Survey 1, and a subset of individuals who completed living donor evaluation, completed Survey 2. After 12 months, chart review for all individuals who completed Survey 1 occurred to determine whether they received a transplant or not, and if not what reasons they were ruled out. No data collection took place at Houston Methodist. | Other | Living Donor Volunteers |
Primary outcome
How Changeable Factors Affect Completion of Living Donor Evaluation for Black, Hispanic, and White Volunteers
Time frame: From onset of evaluation to the outcomes at 12 months
Metrics of interest include whether donor volunteers present for evaluation, defined as attending the first in-person visit, and whether they complete the donor evaluation, defined as finishing all required steps except donation. Both outcomes are measured as yes or no. Investigators will use logistic regression to examine differences in the likelihood of presentation and completion among Black, Hispanic, and White donors. Initial analyses will examine the relationship between race and each outcome separately. Race will then be included in multivariable models, with survey-based factors added by category. Changes in the size or significance of race effects after adjustment will be evaluated. If the association between race and evaluation outcomes is reduced after accounting for specific modifiable factors, these factors may represent potential targets for future interventions.
1 secondary outcome
How Changeable Factors Influence Whether Living Donors Go on to Donate, Including Through Paired Exchange
Time frame: From the onset of evaluation until the date of first documented live kidney donation, assessed up to 18 months
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Donor, run by The Methodist Hospital Research Institute.
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 4 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
How Changeable Factors Affect Completion of Living Donor Evaluation for Black, Hispanic, and White Volunteers (time frame: From onset of evaluation to the outcomes at 12 months). 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 31 Aug 2026.