Living Donor Navigation for Kidney Disease

(PILOT Trial)

Overseen By Jayme E Locke, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Under 18, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Living Donor Navigator (LDN) program, delivered via tele-health, can assist more individuals with end-stage kidney disease in finding living kidney donors. The trial compares in-person sessions at transplant centers with virtual sessions through a local health department. It suits English-speaking patients with end-stage kidney disease who are beginning the transplant process and wish to explore living donation options. As an unphased trial, it provides patients a unique opportunity to contribute to innovative research that could enhance access to living kidney donors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Living Donor Navigator Program is safe?

Research has shown that the Living Donor Navigator (LDN) Program assists kidney transplant candidates and their potential donors throughout the donation process. This program offers education and support, either in person or via tele-health services.

The LDN program does not include any medical treatments or medications, so typical clinical trial safety concerns do not apply. Instead, it focuses on providing guidance and support to simplify the living kidney donation process.

Studies suggest that offering the program through tele-health extends its reach to people in various locations, enhancing accessibility. No reports indicate any safety issues with the program, as it is purely educational and not a medical treatment. Consequently, participants seem to receive it well, and it poses no risks to physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Living Donor Navigator Program because it introduces a personalized approach to finding and guiding living kidney donors, which is a fresh take on the often complex and daunting transplant process. Unlike traditional methods, which can leave patients and potential donors to navigate the system on their own, this program offers dedicated support through either in-person or tele-health sessions. The navigators provide step-by-step assistance, ensuring both transplant candidates and donors have a streamlined and personalized experience. This could significantly increase the number of successful transplants by making the donor process more accessible and less intimidating.

What evidence suggests that the Living Donor Navigator Program is effective for kidney disease?

Research has shown that the Living Donor Navigator (LDN) program, available to participants in this trial either in-person or through tele-health, significantly increases the likelihood of finding a living kidney donor. One study found that people in the program were seven times more likely to receive a kidney from a living donor compared to those not in the program. The tele-health version, another arm of this trial, has proven equally successful, with early results indicating a seven-fold increase in approved donors for participants. Both versions of the program guide transplant candidates and potential donors through the donation process, making it easier and more personal. This approach removes obstacles and makes living kidney donation more accessible. ^{6 7 8 9 10}

Who Is on the Research Team?

Vineeta Kumar, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 with end-stage kidney disease who are evaluating their options for a kidney transplant. It's open to English speakers, including deaf individuals with interpreters. People unwilling to consider living donors or those under 18 cannot participate.

Inclusion Criteria

I am open to considering new organ donors or becoming more comfortable with the idea of receiving a donation.

I am over 18 with end-stage kidney disease and am being evaluated for a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Living Donor Navigator (LDN) program, consisting of four educational sessions over two months, either in-person or via tele-health.

8 weeks

4 sessions (in-person or virtual)

Follow-up

Participants are monitored for the number of live donor screenings and approvals within 3 months.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Living Donor Navigator Program

Trial Overview The study tests if a Living Donor Navigator Program delivered via tele-health can increase living kidney donations compared to standard care. Participants will be randomly assigned to receive the program immediately or after a delay.

How Is the Trial Designed?

Group I: Living Donor Navigator Program In-person Active Control 1 Intervention

The LDN program is designed to help transplant candidates find potential donors, and guide potential living donors through the evaluation/ donation process. The LDN program consists of four educational sessions, with each session building on the last. Each educational session lasts approximately 2 hours and is held once every other week for two months. Each LDN session will be conducted by a living donor navigator. As potential living donors are identified, the living donor navigators will work closely with the potential donors to guide them through each step of the evaluation/donation process to ensure streamlined medical services and a personalized experience. Individuals randomized to LDN in-person will receive the program locally at the transplant center.

Group II: Living Donor Navigator Program Tele-health Active Control 1 Intervention

The LDN program is designed to help transplant candidates find potential donors, and guide potential living donors through the evaluation/ donation process. The LDN program consists of four educational sessions, with each session building on the last. Each educational session lasts approximately 2 hours and is held once every other week for two months. Each LDN session will be conducted by a living donor navigator. As potential living donors are identified, the living donor navigators will work closely with the potential donors to guide them through each step of the evaluation/donation process to ensure streamlined medical services and a personalized experience. Individuals randomized to LDN tele-health will receive the program virtually at a local health department within the Alabama Department of Public Health's tele-health network.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Technology-based interventions (TBI) can significantly enhance awareness and knowledge about living donor kidney transplantation (LDKT), particularly among African American and Hispanic populations, which have seen a decline in LDKT rates.

In a review of 31 studies, 60% of patient-facing TBIs and 75% of donor-facing TBIs showed increased linkage between potential donors and transplant candidates, indicating that customized and accessible TBI can effectively connect these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of technology-based interventions on linking potential kidney donors and transplant candidates: a scoping review. Deshpande, PP., Jariwala, S., Martin, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10842874/

Interpersonal Connections are Important for Virtual Kidney ... ... people who chose to participate in the program were 7 times more likely to receive a living donor kidney transplant. Patients with end-stage kidney disease ...

2. researchgate.net researchgate.net/figure/Study-population-flow-diagram-LDN-Living-Donor-Navigator_fig2_332230180

Study population flow diagram. LDN, Living Donor Navigator. The aim of this study was to describe the perspectives and experiences of Indigenous kidney transplant candidates and recipients, living kidney donors, and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522082442

Kidney transplant candidacy evaluation and waitlisting ... Our study suggests that programs that do not have stringent BMI thresholds may have higher rates of living donor and preemptive transplantation as well as lower ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6773517/

Enhanced Advocacy and Health Systems Training through ... A novel program designed to promote both advocacy and systems training among transplant candidates and their potential living kidney donors.

5. ajkd.org ajkd.org/article/S0272-6386(17)31078-8/fulltext

Evaluation of Kidney Donors: Core Curriculum 2018 This installment of AJKD's Core Curriculum in Nephrology provides readers with the tools necessary for proper evaluation of living kidney donor candidates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9633042/

Greater Community Vulnerability is Associated with Poor ... The Living Donor Navigator (LDN) Program helps patients with ESKD identify living kidney donors and helps living donors navigate the complex evaluation process.

7. kidneyfund.org kidneyfund.org/article/american-kidney-funds-5th-annual-living-donor-report-card-reveals-mixed-progress-calls-urgent-action

Living Donor Protection Report Card Between 2012 and 2022, the annual count of those on dialysis who received a kidney transplant increased by 52%; most of this increase was ...

8. kidney.org kidney.org/news-stories/increasing-living-kidney-donors-alabama

Increasing Living Kidney Donors in Alabama The Living Donor Navigator Program aims to increase kidney transplants in Alabama by removing barriers to living kidney donations for potential recipients and ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961020308138

Self-advocacy is associated with lower likelihood of living ... Self-advocates had lower likelihood of LDKT compared to patients with an advocate. Having a spouse/significant other advocate was significantly associated with ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9516458/

Patient Navigators for CKD and Kidney Failure: A Systematic ... We performed a systematic review to summarize patient navigator program design, evidence, and implementation in kidney disease.