Health TrialsbyHealthPanel

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

ConditionsKidney Transplant; ComplicationsCMV
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cytogam

    Drug

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Single Dose, Day 0Experimental treatment 1 intervention
Group B: Two Doses, One WeekExperimental treatment 1 intervention
Group C: Two Doses, Four WeeksExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
Apply now