Kidney TransplantNCT07793890
Transforming Curiosity Into Donation
An observational study of Kidney Transplant and Kidney Donor, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
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. 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, Kidney Donor, Drop Out
- What is being tested?
- Living Kidney Donor Support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2024to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will be recruited from Houston Methodist Hospital, Cooperman Barnabas Medical Center, and the National Kidney Foundation (NKF) network.
Who may be able to join
- Potential living kidney donor flagged as higher risk for drop-out
- Previous living kidney donors.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Methodist Hospital Research Institute
Houston, Texas, 77030
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Kidney Transplant, Kidney Donor, Drop Out, High Risk, Living Kidney Donation, Living Donor of Kidney
- Being tested
- Living Kidney Donor Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Kidney Donor SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Potential Living Kidney Donors | Not described Receives: Behavioral: Living Kidney Donor Support | |
| Pre-Donation Experience | Investigators will develop and pilot an interview guide with living donors and conduct a mixed methods pre-donation experience study with previous donors and potential living donors to better understand barriers affecting potential donors' decision-making, and what types of support from transplant providers and peer supporters could be most beneficial. | |
| Index Validation | Investigators will follow potential donors who initiate referral in the respective electronic medical record for a 2-year period after initiation of evaluation and evaluate final donation outcomes at the conclusion of that time. Each potential donor will be categorized by their ultimate donation outcome (i.e., donor outcome pending, successfully donated, donor discontinuation, medical/surgical contraindication to donation, recipient reason for non-donation) and compared across risk category (low-, moderate-, or high-risk) as designated by the LD-DROP index. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce Risk of Drop-Out
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.
Measured: From initial donor evaluation through the following six 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 start18 Jul 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy D Waterman, PhD, Study director, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793890
- Sponsor's protocol ID
- PRO00038079
- Other IDs
- R01DK137111
- Status last verified
- Aug 2026
- First submitted
- 27 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meinders AM, Graviss EA, Nguyen DT, Daw J, Lentine KL, Peipert JD, Gaber AO, Axelrod DA, Weng FL, Waterman AD. Determining Predictors of Actual Living Kidney Donation Based on Potential Donor Characteristics. Clin Transplant. 2024 Sep;38(9):e15439. doi: 10.1111/ctr.15439.
PubMed 39190896Lentine KL, Waterman AD, Cooper M, Nagral S, Gardiner D, Spiro M, Rela M, Danovitch G, Watson CJE, Thomson D, Van Assche K, Torres M, Dominguez-Gil B, Delmonico FL; Donation Workgroup Collaborators. Expanding Opportunities for Living Donation: Recommendations From the 2023 Santander Summit to Ensure Donor Protections, Informed Decision Making, and Equitable Access. Transplantation. 2025 Jan 1;109(1):22-35. doi: 10.1097/TP.0000000000005124. Epub 2024 Oct 22.
PubMed 39437374
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
- 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
- ClinicalTrials.gov ID
- NCT07793890
- Acronym / sponsor ID
- PRO00038079
- Conditions
- Kidney Transplant, Kidney Donor, Drop Out, High Risk, Living Kidney Donation, Living Donor of Kidney
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Potential Living Kidney Donors | – | Behavioral: Living Kidney Donor Support |
| Pre-Donation Experience | – | –Investigators will develop and pilot an interview guide with living donors and conduct a mixed methods pre-donation experience study with previous donors and potential living donors to better understand barriers affecting potential donors' decision-making, and what types of support from transplant providers and peer supporters could be most beneficial. |
| Index Validation | – | –Investigators will follow potential donors who initiate referral in the respective electronic medical record for a 2-year period after initiation of evaluation and evaluate final donation outcomes at the conclusion of that time. Each potential donor will be categorized by their ultimate donation outcome (i.e., donor outcome pending, successfully donated, donor discontinuation, medical/surgical contraindication to donation, recipient reason for non-donation) and compared across risk category (low-, moderate-, or high-risk) as designated by the LD-DROP index. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from Houston Methodist Hospital, Cooperman Barnabas Medical Center, and the National Kidney Foundation (NKF) network.
Key inclusion criteria (2 listed)
- Potential living kidney donor flagged as higher risk for drop-out
- Previous living kidney donors.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Living Kidney Donor SupportThis 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. | Behavioural | Potential Living Kidney Donors |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 39190896Meinders AM, Graviss EA, Nguyen DT, Daw J, Lentine KL, Peipert JD, Gaber AO, Axelrod DA, Weng FL, Waterman AD. Determining Predictors of Actual Living Kidney Donation Based on Potential Donor Characteristics. Clin Transplant. 2024 Sep;38(9):e15439. doi: 10.1111/ctr.15439.
- Background: PubMed 39437374Lentine KL, Waterman AD, Cooper M, Nagral S, Gardiner D, Spiro M, Rela M, Danovitch G, Watson CJE, Thomson D, Van Assche K, Torres M, Dominguez-Gil B, Delmonico FL; Donation Workgroup Collaborators. Expanding Opportunities for Living Donation: Recommendations From the 2023 Santander Summit to Ensure Donor Protections, Informed Decision Making, and Equitable Access. Transplantation. 2025 Jan 1;109(1):22-35. doi: 10.1097/TP.0000000000005124. Epub 2024 Oct 22.
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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.
Amy D Waterman, PhD study director
The Methodist Hospital Research Institute
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 and Kidney Donor, run by The Methodist Hospital Research Institute at 1 site in United States.
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 2 inclusion and 6 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: under way, not looking for participants, 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.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reduce Risk of Drop-Out (time frame: From initial donor evaluation through the following six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07793890, which also lists 2 linked publications.
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.