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

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

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.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus Disease
• Intervention / Treatment: Drug: Valganciclovir; Drug: Valganciclovir; Biological: CMV hyperimmune globulin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female patients ≥ 18 years of age.
2. Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
3. 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.
4. The patient has given written informed consent to participate in the study.

Exclusion Criteria:

1. Solid organ transplant recipient is CMV seropositive at the time of transplant.
2. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
3. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
4. 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.
5. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
6. Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
7. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
8. 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.
9. 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.
10. Inability to cooperate or communicate with the investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: CSL Behring

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (Estimate): January 13, 2012

Study Record Updates

• Last Update Posted (Actual): October 4, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: transplant; cytomegalovirus; CMV
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections; Anti-Infective Agents; Antiviral Agents; Valganciclovir
• Other Study ID Numbers: Pro00009601