MuST AKT Program for Kidney Transplant

(MuST AKT Trial)

Overseen By Mr. Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Identified donor, Prior transplant, Multi-organ candidate, SIPAT >20, REALM-66 <19

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with kidney failure find living donors for transplants, which can lead to longer and better-quality lives compared to staying on dialysis. The study will test a new program called MuST AKT, which provides personalized support and education to help patients reach out to their social networks for potential donors. Participants will either receive this new support or continue with the usual care, which involves a standard social worker assessment. This trial suits English-speaking kidney failure patients who haven't found a living donor yet and have completed an introductory kidney transplant module. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative approaches in transplant support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the MuST AKT intervention is safe?

Research has shown that the MuST AKT program, designed to help patients find living kidney donors, is currently being tested for safety and effectiveness. Specific safety information for this program is not yet available. However, MuST AKT is a support program, not a medication or surgery, suggesting it is likely low-risk as it provides guidance and support rather than medical treatment.

The process of finding living kidney donors, which the program aims to facilitate, is generally safe for donors. This aligns the program's goal with practices already recognized as safe. As this trial is in its early stages, the primary focus is on ensuring the program's effectiveness, which typically involves minimal safety concerns.

In summary, while detailed safety data for MuST AKT is not yet available, the program's nature suggests it is safe and low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MuST AKT program for potential kidney transplant recipients because it offers a new, personalized approach to preparing patients for living donor kidney transplants. Unlike the standard of care, which typically involves a social worker assessment, the MuST AKT intervention is a multidisciplinary, tailored behavioral program designed to support and empower patients throughout the transplant process. This approach focuses on addressing individual needs and optimizing the chances of successful transplantation, potentially improving outcomes for patients awaiting a kidney transplant.

What evidence suggests that the MuST AKT intervention is effective for increasing living kidney donor transplants?

Research shows that the MuST AKT program, which participants in this trial may receive, might help people with kidney failure find living donors for kidney transplants. Studies have found that personalized assistance from a team of experts can significantly aid patients in connecting with potential donors among friends and family. This method addresses common issues, such as uncertainty about how to ask someone to be a donor. Early results suggest that MuST AKT could increase the number of living donor transplants, which are typically better for patients than waiting for a kidney from a deceased donor. This could reduce the number of people waiting for kidneys and improve health outcomes for those with kidney failure. ^{1 2 3 4 6}

Who Is on the Research Team?

Dr. Shojai

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with kidney failure who have completed a 'kidney transplant introduction' module and are eligible for a transplant. It's not open to those who already have a donor, have had previous transplants, need multiple organ transplants, or score low on certain psychosocial or literacy tests.

Inclusion Criteria

Successfully completed 'introduction to kidney transplant' module

English speaking

I am eligible for a kidney transplant.

Exclusion Criteria

Previously received organ transplant

Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) Score >20

Potential Living Kidney Donor identified

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MuST AKT intervention, a multidisciplinary, tailored person-centered intervention aimed to support participants in identifying potential donors and communicating with their social network.

3 months

4 sessions (in-person or virtual)

Follow-up

Participants are monitored for kidney transplant status and other outcomes post-intervention.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• MuST AKT

Trial Overview The MuST AKT intervention is being tested to help patients find living kidney donors through their social networks. The goal is to increase the number of living donor kidney transplants in Alberta by providing personalized support from a multidisciplinary team.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This arm will receive the MuST AKT intervention, which is a multidisciplinary, tailored person-centered behavioural intervention designed to "help and enable" the potential kidney transplant recipients to achieve what is required to receive a living donor kidney transplantation.

Group II: Usual Care (control) Active Control 1 Intervention

In the usual care (control) condition, participants will go through the current standard of care, which is a social worker assessment.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37920779/

Multidisciplinary Support To Access living donor Kidney ... We outline a protocol to test the feasibility of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention designed to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05459337?locStr=Canada&country=Canada&cond=renal%20transplant&aggFilters=status:rec%20not&rank=9

Multidisciplinary Support to Access Living Donor Kidney ... The primary objective of this study is to examine the effectiveness of the MuST AKT intervention to increase living donor kidney transplantation outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10619336/

Multidisciplinary Support To Access living donor Kidney ... If the MuST AKT intervention is found to be safe, feasible, and effective for increasing living kidney donation in the definitive RCT (to be ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04666545

Multidisciplinary Support To Access Living Donor Kidney ... The primary objective of this study is to examine the efficacy of the MuST AKT program to facilitate patients' identification of potential living kidney donors ...

5. albertahealthservices.ca albertahealthservices.ca/assets/about/scn/ahs-scn-scnergy-mustakt.pdf

Multidisciplinary Support To Access living donor Kidney ... By helping people find living kidney donors through MuST AKT, other Albertan's with kidney failure will also benefit through reduced wait times for a deceased ...

6. journals.lww.com journals.lww.com/kidney360/fulltext/2024/07000/short_term,_mid_term,_and_long_term_outcomes_after.14.aspx

Short-Term, Mid-Term, and Long-Term Outcomes after ... Observational studies have suggested that kidney transplantation in patients with AKI is feasible and safe, but no systematic evaluation has been performed.