Transforming Curiosity Into Donation

This is a multi-step study that will first create a preliminary living donor drop-out risk index (LD-DROP) by retrospectively identifying factors that contribute to the discontinuation of living donor evaluation. Investigators will then validate the LD-DROP index by prospectively tracking the progress of a large group of individuals presenting for living kidney donor evaluation.

In parallel, investigators will conduct focus groups with previous donors and individual qualitative interviews with potential living donors who vary by race, gender, and level of risk for drop-out, to explore barriers affecting their donation decision-making, and the most helpful interventions for overcoming these barriers.

Finally, using data gathered from the LD-DROP index and individual interviews, investigators will pilot an intervention with potential donors identified to be at a modifiable high risk of drop-out.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Kidney Transplant Drop Out High Risk Kidney Donor Living Donor of Kidney Living Kidney Donation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

About this study

To reduce disparities in living donation and increase living kidney donor transplant (LKDT), investigators propose to:

Aim 1a: Retrospectively identify clinical factors, social determinants of health, and other modifiable factors that are correlated with discontinuation of the donor candidate's evaluation to develop a living donor drop-out risk prediction index, LD-DROP. Subgroup analyses will examine issues specific to racial and ethnic minorities and potential donors of lower socioeconomic status (SES) independently to determine if socioeconomic factors differentially impact donation in minority populations.

Aim 1b: Prospectively validate the LD-DROP index for predicting drop-out during evaluation. Potential donors (n=2000) who initiate referral in the respective electronic medical record will be followed for a 2-year period after initiation to assess final donation outcomes.

Aim 2: Conduct community-engaged research with previous donors (n=12) from the NKF PEERS mentoring program, and potential donors (n=100) from Houston Methodist Hospital Transplant Center (HMH-TC) and Cooperman Barnabas Transplant Center (CB-TC) to better understand how to support potential living donors at high risk for drop-out during evaluation who are Black, Hispanic, have lower SES, and/or are entering the evaluation process at varying levels of readiness.

Aim 3: Pilot an intervention with potential donors (n=73) from HMH-TC and the NKF PEERS mentoring program to support potential donors identified as being at high risk of dropping out from evaluation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Potential living kidney donor flagged as higher risk for drop-out
Previous living kidney donors.

Exclusion criteria

Ruled out from donating by a transplant center
High (≥ 35) or low (≤ 18) body mass index (BMI)
High blood pressure
Diabetes
Concern for undiagnosed kidney disease
Age ≤ 18 years

Treatment and study plan

Living Kidney Donor Support

Behavioral

This intervention is a relational, educational support pilot designed to improve the living donor evaluation experience. It is delivered by educators and conducted primarily by telephone or video conferencing over a six-month period. Potential donors are offered optional monthly touchpoints focused on supporting informed and values aligned decision making, regardless of whether they choose to proceed with donation. During each interaction, educators assess donor experience and readiness, document changes over time, respond to questions and concerns, and provide information about available resources to reduce stress and donor associated financial burden. Participants also receive monthly emailed video digital stories from the Living Donor Storytelling program and are offered the opportunity to connect with a National Kidney Foundation peer mentor. Educators document participant engagement, questions raised, and responses to the supports offered across all touchpoints.

Primary outcomes

Reduce Risk of Drop-Out

Time frame: From initial donor evaluation through the following six months

As a pilot study, participants will not be randomized. Investigators will measure the proportion of potential living kidney donors who remain eligible donor candidates six months after initial donation request. This observed proportion will be compared with an estimated proportion based on LD-DROP (Living Donor Drop-Out Index, derived from patient-reported characteristics and beliefs). For each participant, an expected risk adjusted probability of donor drop-out will be calculated using the LD-DROP score. The observed drop-out rate at six months will be compared with this score to generate an observed to expected ratio. The pilot will be considered successful if the observed dropout rate is at least 25% lower than expected. Time to donor drop out will also be summarized using Kaplan Meier curves that display the proportion of donors remaining active candidates over the six month follow up period.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Transforming Curiosity Into Donation: Validating a Risk Prediction Index to Detect and Prevent Drop-Out in Potential Living Kidney Donors Who Are Racial/Ethnic Minorities

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
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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Active, not recruiting