Preventing CMV with CMVIG after conversion to belatacept in kidney transplant recipients
CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study
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.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07096453 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.