SYN002 for Preventing CMV Transmission in Kidney Transplantation

(RESPECT-CMV Trial)

Overseen By Atul Humar, MD, FRCP(C)

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University Health Network, Toronto

Must not be taking: Belatacept, Alemtuzumab

Disqualifiers: HIV positive, Re-transplantation, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

Donor organs often carry latent Cytomegalovirus (CMV) infection that may be transmitted to the recipient. The goal of this clinical trial is to determine the safety of SYN002 treatment during Ex-Vivo Organ Perfusion (EVOP) in clinical kidney transplantation. Donor kidneys will be treated on the EVOP system with SYN002 in order to decrease the burden of latent CMV in the organ and mitigate the transmission of cytomegalovirus (CMV).

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

* Listed for kidney transplantation

* Willing and able to return for follow-up visits as scheduled in the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 day

1 visit (in-person)

Transplantation and Post-operative Care

Kidneys are transplanted and patients receive standard post-operative care.

4 weeks

Multiple visits (in-person) as per standard care

Follow-up

Participants are monitored for graft function and CMV DNAemia post-transplant.

6 months

Regular visits (in-person) for monitoring

What Are the Treatments Tested in This Trial?

Interventions

• SYN002

How Is the Trial Designed?

Group I: EVOP with SYN002 Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+