SYN002 for Preventing CMV Transmission in Kidney Transplantation
(RESPECT-CMV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called SYN002, an experimental therapy aimed at preventing the spread of cytomegalovirus (CMV), a common virus, during kidney transplants. The treatment is applied to donor kidneys before transplantation to reduce the virus's presence and its likelihood of spreading to the recipient. Individuals listed for a kidney transplant, regardless of previous CMV exposure, may qualify for this trial. As an Early Phase 1 trial, the research focuses on understanding how SYN002 works in people, providing participants the opportunity to be among the first to receive this novel treatment.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you cannot participate if you plan to use certain immunosuppressive drugs like belatacept or alemtuzumab.
What prior data suggests that SYN002 is safe for use in Ex-Vivo Organ Perfusion?
Research has shown that SYN002 appears safe for use in kidney transplants. Studies found that SYN002, when used to prepare kidneys for transplant, was well-tolerated, with no major safety concerns. It also helped reduce levels of Cytomegalovirus (CMV) in the treated kidneys.
The current trial is in an early phase, focusing on assessing the safety of SYN002. This indicates that the treatment is still undergoing testing in humans, but reaching this stage suggests that earlier tests, likely on animals or in labs, did not reveal major safety issues. Consider this information if thinking about joining a trial with SYN002.12345Why do researchers think this study treatment might be promising?
Most treatments for preventing CMV transmission in kidney transplantation involve antiviral medications that patients take after the transplant. But SYN002 works differently by being directly administered to the donor kidney before transplantation using the EVOP platform. This approach allows for targeted treatment right at the source, potentially reducing the risk of CMV transmission. Researchers are excited because SYN002 might offer a safer and more effective method by using a controlled dose escalation, which has shown promising results in pre-clinical testing.
What evidence suggests that SYN002 is effective for preventing CMV transmission in kidney transplantation?
Research has shown that SYN002, which participants in this trial will receive, can significantly reduce the reactivation of cytomegalovirus (CMV) in donor kidneys. In studies, kidneys treated with SYN002 experienced over a 90% reduction in CMV reactivation compared to untreated ones. This reduction improves kidney function after a transplant. SYN002 targets the virus during a process that treats organs outside the body before transplantation. The goal is to lower the risk of CMV spreading to the transplant recipient, a common issue despite standard preventive measures. Early results suggest SYN002 could transform CMV management in transplants.23456
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) who are on the waiting list for a kidney transplant, can attend follow-up visits, aren't in other treatment trials, and agree to give informed consent. Both people with and without prior CMV exposure can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Ex Vivo Organ Perfusion (EVOP) Treatment
Donor kidneys are treated with SYN002 on the EVOP platform for approximately 4 hours to decrease latent CMV before transplantation.
Transplantation and Post-operative Care
Kidneys are transplanted and patients receive standard post-operative care.
Follow-up
Participants are monitored for graft function and CMV DNAemia post-transplant.
What Are the Treatments Tested in This Trial?
Interventions
- SYN002
Trial Overview
The study tests if treating donor kidneys outside the body with SYN002 before transplantation can safely reduce the risk of passing on cytomegalovirus (CMV) from donor to recipient.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Donor kidneys will be treated with SYN002 administered on the EVOP platform. Normothermic perfusion of kidney will be preformed for approximately 4 hours. Prior to transplant, the kidneys will be flushed to remove any residual SYN002 Transplantation and post-operative care will be as per standard of care. The target dose of SYN002 will 850ng/ml; This dose has been shown to be safe and effective in pre-clinical testing. However, we will perform a dose escalation as follows: Cohort 1: 50 ng/ml (n=2); Cohort 2: 150 ng/ml (n=2); Cohort 3: 450 ng/ml (n=2); Cohort 4: 850 ng/ml (n=6).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Citations
Inhibition of cytomegalovirus reactivation by ex vivo ...
Administration of SYN002 significantly reduced the level of HCMV in kidneys, with no such decrease in control kidneys. There was no significant ...
Synklino announces publication in American Journal of ...
Despite standard of care prophylaxis, approximately 30% of patients who receive a CMV-positive donor organ still experience CMV reactivation.
Synklino announces publication in American Journal of
These findings demonstrate that SYN002 has the potential to fundamentally change how CMV is managed in transplantation, by intervening at the ...
SYN002 for Preventing CMV Transmission in Kidney ...
Donor kidneys are treated with SYN002 on the EVOP platform for approximately 4 hours to decrease latent CMV before transplantation. 1 day. 1 ...
Real-World Off-Label Use of Letermovir Prophylaxis for ...
Letermovir is approved for CMV prophylaxis in high-risk kidney transplant recipients, but data on its use outside of that population are limited. We describe ...
NCT06798909 | Kidney Transplant Preemptive Therapy or ...
This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) ...
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