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OpenTrials
Completed

NCT Number: NCT07793877

Modifiable Factors Affecting Racial Disparities in Kidney Donation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Live kidney donor volunteer

Exclusion criteria

  • 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

Treatment and study plan

Not applicable- observational study

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Modifiable Factors Affecting Live Donor Disparities (MFALDD) - Living Donors Secondary Analysis

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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