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RecruitingNCT07096453Updated Oct 7, 2026

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

A Phase 1/2 interventional study of Cytogam in Kidney Transplant; Complications and CMV, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by University of Minnesota · Phase 1/2, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to study how CMVIG interacts with the body and to see if it might work to prevent kidney transplant patients from becoming infected with CMV.

02

Conditions studied

  • Kidney Transplant; Complications
  • CMV

Keywords

  • Kidney transplant
  • CMV prevention
03

In context

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Single Dose, Day 0

    CMVIG 150 mg/kg x 1 at Day 0. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.

    Drug: Cytogam

  • Experimental
    Two Doses, One Week

    CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 7. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.

    Drug: Cytogam

  • Experimental
    Two Doses, Four Weeks

    CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 28. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.

    Drug: Cytogam

Interventions

  • DrugCytogam

    Cytogam is used for the prevention of cytomegalovirus (CMV) disease in kidney, lung, liver, pancreas, heart and bone marrow transplantation. We do not yet have data about how much cytogam reduces CMV in blood, or how quickly it reduces CMV in blood.

06

What researchers measure

Primary outcomes

  1. Anti-CMV IgG antibody level: Day 0

    Measured with ELISA testing

    Time frame: Day 0, pre-infusion

  2. Anti-CMV IgG antibody level: Day 7

    Measured with ELISA testing

    Time frame: Day 7

  3. Anti-CMV IgG antibody level: Day 14

    Measured with ELISA testing

    Time frame: Day 14

  4. Anti-CMV IgG antibody level: Day 21

    Measured with ELISA testing

    Time frame: Day 21

  5. Anti-CMV IgG antibody level: Day 28

    Measured with ELISA testing

    Time frame: Day 28

  6. Anti-CMV IgG antibody level: Day 56

    Measured with ELISA testing

    Time frame: Day 56 after last dose of CMVIG

07

Study locations

1 of 1 sites recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
    • Mary Farnsworth · Contact · ewigx005@umn.edu · 612-624-9695
    • Vanessa Humphreville, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07096453
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jul 31, 2025
Start date
Oct 2, 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Elise Reed
Contact
surgcto@umn.edu
612-624-9695
Vanessa Humphreville, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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