Kidney Transplant; ComplicationsPhase 1/2NCT07096453
CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients
A Phase 1/2 study testing Cytogam in people with Kidney Transplant; Complications and CMV, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant; Complications, CMV
- What is being tested?
- Cytogam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to Aug 2027
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Mary Farnsworth, 612-624-9695, ewigx005@umn.edu
Vanessa Humphreville, MD
About this study
Official title: CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study
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.
- Conditions
- Kidney Transplant; Complications, CMV
- Being tested
- Cytogam
- Keywords
- Kidney transplant, CMV prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytogamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose, Day 0 | Experimental | 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. Receives: Drug: Cytogam |
| Two Doses, One Week | Experimental | 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. Receives: Drug: Cytogam |
| Two Doses, Four Weeks | Experimental | 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. Receives: Drug: Cytogam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-CMV IgG antibody level: Day 0
Measured with ELISA testing
Measured: Day 0, pre-infusion
Anti-CMV IgG antibody level: Day 7
Measured with ELISA testing
Measured: Day 7
Anti-CMV IgG antibody level: Day 14
Measured with ELISA testing
Measured: Day 14
Anti-CMV IgG antibody level: Day 21
Measured with ELISA testing
Measured: Day 21
Anti-CMV IgG antibody level: Day 28
Measured with ELISA testing
Measured: Day 28
Anti-CMV IgG antibody level: Day 56
Measured with ELISA testing
Measured: Day 56 after last dose of CMVIG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start2 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Humphreville, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096453
- Sponsor's protocol ID
- SURG-2024-32817
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study
- ClinicalTrials.gov ID
- NCT07096453
- Acronym / sponsor ID
- SURG-2024-32817
- Conditions
- Kidney Transplant; Complications, CMV
- Keywords
- Kidney transplant, CMV prevention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose, Day 0 | Experimental | Drug: CytogamCMVIG 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. |
| Two Doses, One Week | Experimental | Drug: CytogamCMVIG 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. |
| Two Doses, Four Weeks | Experimental | Drug: CytogamCMVIG 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytogamCytogam 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. | Drug | Single Dose, Day 0, Two Doses, Four Weeks, Two Doses, One Week |
Primary outcome
Anti-CMV IgG antibody level: Day 0
Time frame: Day 0, pre-infusion
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 7
Time frame: Day 7
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 14
Time frame: Day 14
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 21
Time frame: Day 21
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 28
Time frame: Day 28
Measured with ELISA testing
Anti-CMV IgG antibody level: Day 56
Time frame: Day 56 after last dose of CMVIG
Measured with ELISA testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanessa Humphreville, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cytogam in people with Kidney Transplant; Complications and CMV, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 7 Oct 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Elise Reed (612-624-9695, surgcto@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-CMV IgG antibody level: Day 0 (time frame: Day 0, pre-infusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.