Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 70

Preventing CMV with CMVIG after conversion to belatacept in kidney transplant recipients

Official title: CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study

Run by University of Minnesota · NCT07096453 · Data updated 2026-11-12

This will try CMVIG infusions to prevent CMV infection in adult kidney transplant recipients who are CMV‑seronegative and are switching to or already on belatacept.

More Kidney Transplant trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment30 (estimated)
SponsorUniversity of Minnesota
Academic / other
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedOctober 2, 2025
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedOctober 7, 2026
Trial IDNCT07096453 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adult (18–70) kidney transplant recipients who are CMV IgG negative, received an IgG‑positive donor organ, are EBV IgG positive, and are switching to or already on belatacept are ideal candidates.

Probably not a fit

Patients who are CMV seropositive, pregnant, have IgA deficiency, recent IgG therapy, or cannot consent in English are unlikely to be eligible or benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, single‑center interventional study gives Cytogam (CMV immune globulin) to adult kidney transplant recipients who are CMV IgG–negative and received a CMV IgG–positive donor (D+/R-), either at the time of conversion from CNI‑based immunosuppression to belatacept or while stable on belatacept. Participants will receive scheduled CMVIG infusions and be followed for CMV infection, pharmacokinetics, and safety outcomes. The trial focuses on tolerability and whether CMVIG lowers CMV infection rates in this high‑risk population. All enrollment and follow‑up visits occur at the University of Minnesota.

Why it matters

Potential benefit: If successful, CMVIG could reduce CMV infection and its complications in high‑risk CMV D+/R- kidney transplant recipients receiving belatacept.

How similar studies have gone: CMVIG has been used in transplant settings with mixed results and limited high‑quality evidence, and it has not been widely tested specifically during conversion to belatacept.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult (18-70 year old) kidney transplant recipients
* Patients transitioning from conventional CNI-based immunosuppression to co-stimulatory blockade (belatacept) immunosuppression OR patients who are stable on belatacept immunosuppression at the time of initial CYTOGAM infusion
* CMV Ig Seronegative Recipient who received a CMV Ig seropositive Donor
* EBV IgG Positive

Exclusion Criteria:

* Pregnant people
* Subjects unwilling to sign consent and complete follow up visits
* Subjects with IgA immunodeficiency
* Subjects who are receiving IgG therapy or who have received IgG therapy within two months of study enrollment
* Patients who do not speak English and would need a translator and translated consent materials in order to obtain informed consent

Where it's running

  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: Vanessa Humphreville, MD — University of Minnesota
  • Study coordinator: Elise Reed
  • Email: surgcto@umn.edu
  • Phone: 612-624-9695

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.