Health TrialsbyHealthPanel

Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

ConditionsCytomegalovirus (CMV) InfectionKidney Transplant Recipient
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Listed for kidney transplantation

Either CMV seronegative or seropositive

Willing to provide written informed consent to take part in the trial

Disqualifiers

Listed for combined organ transplant (e.g. kidney-pancreas or kidney-liver)

Re-transplantation

HIV positive

Highly sensitized recipient with a PRA >=95

Trial design

Design model

Single group

Treatments tested in this trial

  • SYN002

    Drug

    SYN002, a fusion protein targeting US28, a human cytomegalovirus (CMV) - specific virally encoded receptor expressed on both latent and lytic CMV-infected cells.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: EVOP with SYN002Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Graft function

Proportion of patients with a functioning graft at 4 weeks post-transplant defined as no longer needing dialysis at 4 weeks

Time frame
4 weeks post-transplant

Secondary outcomes

1

Delayed graft function

a. Proportion of patients with delayed graft function with requirement for dialysis post-transplant

Time frame
4 weeks post-transplant
2

CMV DNAemia 3 months

Proportion of patients that develop CMV DNAemia with plasma viral load \> 1000 IU/ml at 3 months post-transplant

Time frame
3 months post-transplant
3

Length of hospital stay

Median days of hospital stay

Time frame
6 months post-transplant
4

Graft survival 3 months

Proportion of patients with a functioning graft

Time frame
3 months post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: