Live Donor Champion Program for Kidney Disease

(LDC Trial)

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Live donors under evaluation, previous transplant

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people on the kidney transplant waitlist learn about kidney disease and find live kidney donors. Participants will attend sessions to gain knowledge and skills for raising awareness and identifying potential donors. Friends and family can join as "live donor champions" to support and advocate for the patient. Those on the kidney transplant waitlist for less than a year without potential live donors are a good fit for this program. As an unphased trial, this study offers patients a unique opportunity to gain valuable support and resources in their journey toward finding a live kidney donor.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems to focus on education and support rather than medical treatment, so you likely won't need to change your medications.

What prior data suggests that the Live Donor Champion Program is safe?

In a previous study, researchers found that kidney transplants from living donors improved both the survival rates of the transplanted kidney and the recipient's life expectancy and quality of life. The Live Donor Champion Program aims to raise awareness about kidney donation and assist patients in finding potential donors.

As an educational program, it poses no safety concerns related to medical treatments. Participants attend sessions led by transplant experts to learn about kidney disease, develop communication skills, and hear personal stories. Thus, the program itself involves no medical risks. Instead, it offers valuable information and support for those interested in learning more about living kidney donation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Live Donor Champion Program for kidney disease because it takes a fresh approach by focusing on education and empowerment rather than medical treatment. Unlike traditional options for end-stage renal disease, such as dialysis or kidney transplantation alone, this program equips patients and their social networks with crucial knowledge and skills. Through interactive sessions involving storytelling and role-playing, participants learn to communicate effectively and explore potential living kidney donors within their social circles. This unique method aims to increase the number of live kidney donations, enhancing patient outcomes and offering a more sustainable solution to kidney disease.

What evidence suggests that the Live Donor Champion Program is effective for kidney disease?

Research has shown that kidney transplants from living donors, supported by the Live Donor Champion Program in this trial, lead to better survival rates for the transplanted kidney. Participants in similar programs have experienced longer lives and improved quality of life. In this trial, participants will engage in the Live Donor Champion Program, which educates patients about kidney disease and transplants. By involving family and friends as "live donor champions," the program facilitates finding potential donors. This approach increases the chances of successful transplants by spreading awareness and support. ^{1 6 7 8 9}

Who Is on the Research Team?

Elizabeth King, MD PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 on the kidney transplant waitlist within the last year without live donors. It's open to English speakers at University or University of Alabama, and English or Spanish speakers at Northwestern University. Friends or family willing to advocate for patients can join as 'Live Donor Champions'. Those with potential donors under evaluation or previous transplants are excluded.

Inclusion Criteria

I am over 18, need a kidney transplant, and have no live donors.

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

You are a friend, family member, or community member willing to speak up for the patient on the waiting list.

Exclusion Criteria

Candidates with live donors currently under evaluation for donation will be excluded.

Those with a previous kidney transplant will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants and their Live Donor Champions attend 6 monthly sessions focusing on education about ESRD, KT, LDKT, communication skills, exploring social networks, sharing stories, and building self-efficacy.

6 months

6 visits (in-person)

Follow-up

Participants are monitored for the sustainability, penetration, acceptability, feasibility, appropriateness, fidelity, adoption, and cost of the program.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Live Donor Champion Program

Trial Overview The Live Donor Champion Program educates patients about kidney failure, transplantation, and finding live donors. The study tests how well this program works in a clinical setting by helping participants increase their knowledge and identify potential donors through support from friends and family acting as advocates.

How Is the Trial Designed?

Group I: Live Donor Champion Experimental Treatment 1 Intervention

The Live Donor Champion program is the sole educational intervention for this trial. LDC consists of 6 monthly sessions of approx. 1 hour each. Each LDC session is led by a transplant physician or clinical coordinator. LDC sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LDC sessions are as follows: 1) education about ESRD, KT, and LDKT 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) encouraging candidate self-efficacy 6) Program Recap.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4826649/

Outcomes of Live Kidney Donors who Develop End Stage ... INTRODUCTION. Carefully screened live kidney donors have a demonstrated, albeit low, risk of end stage renal disease (ESRD) following donor nephrectomy.

2. withpower.com withpower.com/trial/phase-kidney-failure-chronic-4-2018-1aac4

Live Donor Champion Program for Kidney Disease ... The research shows that living donor kidney transplants lead to better survival rates for the transplanted kidney and improved life expectancy and quality for ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03099434

Expanding Live Donor Kidney Transplantation Through ... This pilot study will be a clinical trial to test the feasibility and effectiveness of an educational intervention and a mobile health intervention in adults ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3374007/

Finding Live Kidney Donors by Separating the Advocate ... We developed an intervention to train a Live Donor Champion (LDC) (a friend, family member, or community member willing to advocate for the candidate) for this ...

5. researchgate.net researchgate.net/publication/223989782_Live_Donor_Champion_Finding_Live_Kidney_Donors_by_Separating_the_Advocate_From_the_Patient

Finding Live Kidney Donors by Separating the Advocate ... We compared outcomes of 15 adult kidney transplant candidates who had no prospective donors and underwent the LDC intervention with 15 matched ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26457599/

Outcomes of Live Kidney Donors Who Develop End-Stage ... Abstract. Background: Kidney donors can develop end-stage renal disease (ESRD) after donation, but the outcomes of those who do remain poorly characterized.

7. ajkd.org ajkd.org/article/S0272-6386(21)00054-8/fulltext

Quantifying Risk Tolerance Among Potential Living Kidney ... In summary, at the time of donor evaluation most potential LKDs are willing to accept at least a 0.9% chance of developing kidney failure after ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522001654

Consensus Conference on Best Practices in Live Kidney ... Live donor kidney transplantation (LDKT) is the best treatment for most patients with late-stage kidney disease, accounting for more than one-third of kidney ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4189686/

End-stage renal disease risk in live kidney donors We review two recent publications that describe the long-term risk of end-stage renal disease (ESRD) in living kidney donors.