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Cytomegalovirus (CMV) InfectionEarly Phase 1RESPECT-CMVNCT07488481

Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

A Early Phase 1 study testing SYN002 in people with Cytomegalovirus (CMV) Infection and Kidney Transplant Recipient, run by University Health Network, Toronto at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SYN002
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
16 Mar 2026to 31 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Recipient Inclusion Criteria:

  • Age ≥18 years
  • Listed for kidney transplantation
  • Either CMV seronegative or seropositive
  • Willing to provide written informed consent to take part in the trial
  • Willing and able to return for follow-up visits as scheduled in the protocol
  • Not participating in other interventional trials

Recipient Exclusion Criteria:

  • Listed for combined organ transplant (e.g. kidney-pancreas or kidney-liver)
  • Re-transplantation
  • HIV positive
  • Highly sensitized recipient with a PRA >=95
  • Planned use of belatacept or alemtuzumab immunosuppression (both non-approved drugs in Canada)
  • Unable or unwilling to comply with study procedures

Donor Inclusion Criteria:

  • Deceased donor
  • CMV seropositive (D+)
  • Donor kidney meets criteria for transplantation
  • Single renal artery (required anatomy to perform EVOP)

Donor Exclusion Criteria:

  • CMV seronegative
  • Donor kidney not suitable for transplantation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Atul Humar, MD, FRCP(C) contact

416-340-4241

atul.humar@uhn.ca

Canada1 site

  • University Health Network, Toronto General Hospital, Ajmera Transplant Centre

    Toronto, Ontario, M5G 2N2

    Ilona Bahinskaya, MSc, CCRP, 416-340-4800 ext. 4328, Ilona.Bahinskaya@uhn.ca

Other trials in Canada

About this study

Official title: Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission: A Safety Trial in Kidney Transplant Recipients

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).

Read the detailed description

Cytomegalovirus (CMV) is the most common viral infection in transplant recipients and has major impacts on patient outcomes. It can cause fever, pneumonia, gastrointestinal disease, and lead to rejection of the kidney. To prevent this, transplant recipients receive prolonged antiviral drugs. This leads to significant drug toxicity and cost, and is often not successful. The risk of CMV is much higher if the donor organ carries latent CMV inside it (approximately 50-70% of donor organs). A much better and safer strategy would therefore be to try to eliminate the latent virus from the donor organ prior to transplantation. Ex Vivo Organ Perfusion (EVOP) is a common method of donor organ preservation and treatment which allows donor organs to be treated for several hours under close to physiological conditions.

The investigators propose a study in which kidneys will be treated prior to transplantation on the EVOP platform in order to decrease latent CMV. SYN002 is a novel compound that binds to cells that are latently infected with CMV and is internalized and kills those specific cells. This pilot study will involve 12 kidney transplant patients, who are receiving a kidney known to have latent CMV. The kidney will be treated with SYN002 on the EVOP system prior to transplantation.

Being tested
SYN002
Keywords
Cytomegalovirus, Kidney Transplantation, Ex-vivo organ perfusion
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYN002Drug

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

Study groups in NCT07488481
Study groupRoleWhat they receive
EVOP with SYN002ExperimentalDonor 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).
Receives: Drug: SYN002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Graft function

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

    Measured: 4 weeks post-transplant

Secondary outcomes (7)

  1. Delayed graft function

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

    Measured: 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

    Measured: 3 months post-transplant

  3. Length of hospital stay

    Median days of hospital stay

    Measured: 6 months post-transplant

  4. Graft survival 3 months

    Proportion of patients with a functioning graft

    Measured: 3 months post-transplant

  5. Graft survival 6 months

    Proportion of patients with a functioning graft

    Measured: 6 months

  6. CMV DNAemia 6 months

    Proportion of patients that develop CMV DNAemia with plasma viral load > 1000 IU/ml at 6 months post-transplant

    Measured: 6 months post-transplant

  7. CMV disease

    Proportion of patients with CMV disease

    Measured: 6 months post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start16 Mar 2026 (estimated)
  3. Primary completion16 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Interventional Phase 1 Single Group Assignment
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07488481
Sponsor's protocol ID
25-5953
Acronym
RESPECT-CMV
Status last verified
Feb 2026
First submitted
12 Mar 2026
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only aggregate data will be shared for privacy reasons

Publications

  • Ribeiro RVP, Ku T, Wang A, Pires L, Ferreira VH, Michaelsen V, Ali A, Galasso M, Moshkelgosha S, Gazzalle A, Jeppesen MG, Rosenkilde MM, Liu M, Singer LG, Kumar D, Keshavjee S, Sinclair J, Kledal TN, Humar A, Cypel M. Ex vivo treatment of cytomegalovirus in human donor lungs using a novel chemokine-based immunotoxin. J Heart Lung Transplant. 2022 Mar;41(3):287-297. doi: 10.1016/j.healun.2021.10.010. Epub 2021 Oct 25.

    PubMed 34802874

  • Kotton CN, Kumar D, Manuel O, Chou S, Hayden RT, Danziger-Isakov L, Asberg A, Tedesco-Silva H, Humar A; Transplantation Society International CMV Consensus Group. The Fourth International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2025 Jul 1;109(7):1066-1110. doi: 10.1097/TP.0000000000005374. Epub 2025 Apr 9. No abstract available.

    PubMed 40200403

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SYN002 in people with Cytomegalovirus (CMV) Infection and Kidney Transplant Recipient, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Atul Humar, MD, FRCP(C) (416-340-4241, atul.humar@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Graft function (time frame: 4 weeks post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07488481, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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