MuST AKT for Kidney Transplant

(MuST AKT Trial)

Overseen By Dr. Selzler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Identified donor, Prior transplant, Multi-organ candidate, others

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

Compensation: Varies

Number of Visits: 5

38 Participants Needed

Trial Summary

What is the purpose of this trial?

For patients with kidney failure the two treatment options are kidney transplantation or dialysis. Transplantation offers longer survival, better quality of life and provides cost savings for the health system (\>$60,000/year per patient). Unfortunately, there are not enough organs available and 20% of patients die on dialysis waiting for a deceased donor kidney. Living kidney donation is a safe and proven treatment that leads to even better patient and health system outcomes than deceased donor kidney transplant. The Kidney Health Strategic Clinical Network (KH-SCN) identified increasing living kidney donation as a priority and in 2015 established the Living Donor Kidney Transplant Working Group (LDKTWG) comprised of patients, donors, health care professionals, researchers, and administrators. In an evidenced review published by the investigators, the intervention with the best evidence and greatest impact was personalized support provided by a multidisciplinary team to inform and educate the patients' social network. This intervention increased living kidney donations by 34%. The investigators confirmed through a province wide survey that many patients with kidney failure are unable to find a living kidney donor and find it difficult to approach potential donors due to lack of skills, supports, and resources and these issues are particularly apparent in vulnerable populations. The investigators have developed the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention to support patients in identifying and communicating with their social networks. The investigators will test the effectiveness of this intervention.

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 data supports the effectiveness of the treatment MuST AKT for kidney transplant?

The research highlights that while outcomes for third and fourth kidney transplants are less clear, new immunosuppressive treatments have been developed to improve short-term outcomes and maintain long-term survival and quality of life after kidney transplants. This suggests that treatments like MuST AKT, which may involve modern immunosuppressive strategies, could potentially be effective in improving transplant success. ^{1 2 3 4 5}

Is MuST AKT safe for humans?

There is no specific safety data available for MuST AKT, but similar treatments like mammalian target of rapamycin inhibitors have been linked to increased mortality in kidney transplant patients. It's important to discuss potential risks with your healthcare provider. ^{6 7 8 9 10}

Research Team

Dr. Shojai

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for English-speaking patients with kidney failure who have completed an 'introduction to kidney transplant' module and are eligible for a transplant. It's not for those who've had previous transplants, have high psychosocial risk scores, already identified a donor, can't read basic health-related English or need multiple organ transplants.

Inclusion Criteria

I speak English.

I am a suitable candidate for a kidney transplant.

I have completed the kidney transplant introduction module.

Exclusion Criteria

I am eligible for a transplant involving multiple organs.

Your SIPAT score is higher than 20, indicating significant psychological and social challenges that may affect your ability to undergo a transplant.

You have been identified as a possible kidney donor for someone else.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Intervention

Participants receive the MuST AKT program, a multidisciplinary, tailored person-centered intervention aimed to support identification of potential donors and communication with their social network

3 months

4 sessions (virtual or in-person)

Follow-up

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

24 months

Periodic follow-up (virtual or in-person)

Treatment Details

Interventions

• MuST AKT

Trial Overview The MuST AKT intervention is being tested to see if it helps patients with kidney failure find living kidney donors by providing personalized support from a multidisciplinary team to educate their social networks about donation.

Participant Groups

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+

University Hospital Foundation

Collaborator

Trials

8

Recruited

1,800+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Graft survival of fourth-time renal transplant recipients is similar to third-time recipients: A SRTR database analysis. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Immunosuppressive treatment options in renal transplantation. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

How to maximize graft survival. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Our evolving understanding of late kidney allograft failure. [2014]

5. Spain pubmed.ncbi.nlm.nih.gov

[Surgical aspects in the third and fourth kidney retransplant]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

HLA antibodies and the occurrence of early adverse events in the modern era of transplantation: a collaborative transplant study report. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Mammalian Target of Rapamycin Inhibitors and Clinical Outcomes in Adult Kidney Transplant Recipients. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of mobile technology to screen for drug-drug interactions in kidney transplant patients. [2014]

9. Japan pubmed.ncbi.nlm.nih.gov

Incidence of malignancy after pediatric kidney transplantation: a single-center experience over the past three decades in Japan. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of everolimus in maintenance kidney transplant patients in the real-world setting: results from a 2-year post-marketing surveillance study in Japan. [2021]