Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

ConditionsCytomegalovirus Organ Transplant Kidney Transplant; Complications Liver Transplant Complications Simultaneous Liver-Kidney Transplantation; Complications

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCamille N. Kotton, MD

About this trial

This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.

Eligibility criteria

Qualifiers

High risk pretransplant CMV donor seropositive/recipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients

Able to do routine blood testing (normal care for transplant recipients)

Written informed consent obtained from the subject before any trial-related procedures

Be ≥18 years and ≤75 years of age at time of consent

Disqualifiers

Any pre-transplant CMV serologic combinations besides CMV D+/R-

Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant

Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients

Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis

Trial design

Treatments tested in this trial

Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months

Treatment groups

80 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Camille N. Kotton, MD

Lead sponsor

Massachusetts General Hospital

Sponsor institution

University of Texas Southwestern Medical Center

Collaborator

Kamada, Ltd.

Collaborator

Source ClinicalTrials.gov