Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.

Official Title
-----------------
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection

Conditions
-----------------
Cytomegalovirus Disease

Intervention / Treatment
-----------------
* Drug: Valganciclovir
* Biological: CMV hyperimmune globulin
* Drug: Valganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients ≥ 18 years of age. Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion. The patient has given written informed consent to participate in the study. Exclusion Criteria: Solid organ transplant recipient is CMV seropositive at the time of transplant. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV). Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives. Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant. Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication. Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator. Inability to cooperate or communicate with the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Valcyte<br>valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant | Drug: Valganciclovir<br>* Valcyte per package insert guidelines for 200 days post transplant<br>* Other names: Valcyte;|
| Active Comparator: Valcyte then Cytogam<br>valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection | Biological: CMV hyperimmune globulin<br>* 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant<br>* Other names: Cytogam;Drug: Valganciclovir<br>* valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant<br>* Other names: Valcyte;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Late CMV Disease | Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant | after 200 days post-transplant until 2 years post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Early CMV Infection |  | 100 days | 
| Number of Patients With Cell Mediated Immunity | Positive CMV quantiferon at last follow-up | 2 years | 
| Renal Function | Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant | 6, 12, and 24 months after transplant | 
| Number of Participants With Acute Cellular and/or Antibody Mediated Rejection |  | 2 years | 
| Number of Participants With Opportunistic Infections |  | 2 years | 
| Number of Participants With Asymptomatic CMV Viremia |  | 2 years | 
| Number of Participants With CMV Seroconversions |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CMV, cytomegalovirus, transplant