Transforming Curiosity Into Donation

NCT07793890 | Active Not Recruiting

• 2 other identifiers: PRO00038079R01DK137111
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From initial donor evaluation through the following six months

Study Arms (3)

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.

Interventions

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.

Potential Living Kidney Donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from Houston Methodist Hospital, Cooperman Barnabas Medical Center, and the National Kidney Foundation (NKF) network.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 39190896 BACKGROUND

• Lentine 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.

  PMID: 39437374 BACKGROUND

Study Officials

• Amy D Waterman, PhD

  The Methodist Hospital Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: August 31, 2026
• Study Start: July 18, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

US (1)