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

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

For people living with kidney failure, the two active treatment options are dialysis or kidney transplantation. Transplantation is optimal, and especially from a living donor - offering patients longer survival, a better quality of life, and cost savings for the health system when compared to dialysis. However, 20% of patients die on dialysis while waiting for a deceased donor organ. As the rate of kidney failure continues to rise, the gap between demand and supply of the organs for transplantation increases. Compared to other provinces in Canada, the rate of living kidney donor transplantation is lower in Alberta, so it is essential that improvements are made to the process around living kidney donor transplantation, for better patient outcomes and care. Our published evidence-based review on strategies to increase living kidney donation, found that for patients with kidney failure, the intervention with the greatest health impact was personalized support, provided by a multidisciplinary team, to inform and educate the patients' social network. A province-wide survey also confirmed that many patients with kidney failure are unable to find a living kidney donor and also find it difficult to approach potential donors due to lack of skills, supports, and resources. The investigators have developed the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention to support potential kidney transplant recipients find living donors through their social networks, and thereby increase the number of living kidney donor transplants in Alberta. 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.

Is the MuST AKT treatment generally safe for humans?

There is no specific safety data available for MuST AKT treatment in the provided research articles. ^{1 2 3 4 5}

How does the MuST AKT drug differ from other treatments for kidney transplant patients?

The MuST AKT drug may target the Akt signaling pathway, which is involved in cell survival and inflammation, potentially offering a novel approach compared to traditional immunosuppressive drugs like rapamycin that inhibit this pathway and are associated with prolonged delayed graft function. ^{6 7 8 9 10}

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

The Akt pathway, which is targeted by the MuST AKT treatment, is known to play a crucial role in cell survival and proliferation, and has been a focus in cancer therapy due to its involvement in cell growth and protection from cell death. This suggests that targeting Akt could potentially help in managing conditions that require cell survival and growth, such as in kidney transplants. ^{11 12 13 14 15}

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. Netherlands pubmed.ncbi.nlm.nih.gov

The Akt pathway: molecular targets for anti-cancer drug development. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Inhibition of Akt with small molecules and biologics: historical perspective and current status of the patent landscape. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

Activation of PI3K/Akt signaling and hormone resistance in breast cancer. [2019]

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

AKT/PKB signaling: navigating downstream. [2022]

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

Phospho-Akt overexpression in non-small cell lung cancer confers significant stage-independent survival disadvantage. [2021]

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

No Significant Influence of Reduced Initial Tacrolimus Dose on Risk of Underdosing and Early Graft Function in Older and Overweight Kidney Transplant Recipients. [2021]

7. 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]

8. 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]

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

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Ischemia-reperfusion induces glomerular and tubular activation of proinflammatory and antiapoptotic pathways: differential modulation by rapamycin. [2023]

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

The Bergamo Kidney Transplant Program. [2007]

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

A prospective randomized trial of steroid-free maintenance regimens in kidney transplant recipients--an interim analysis. [2023]

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

Immunosuppressive regimens and their effects on renal allograft outcome. [2021]

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

Immunosuppression for dual kidney transplantation with marginal organs: the old is better yet. [2023]