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

• ClinicalTrials.gov Identifier: NCT01509404
• Recruitment Status: Completed
• First Posted: January 13, 2012
• Results First Posted: October 4, 2018
• Last Update Posted: October 4, 2018
• Sponsor: Medical University of South Carolina
• Collaborator: CSL Behring
• Information provided by (Responsible Party): Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cytomegalovirus Disease	Drug: Valganciclovir; Biological: CMV hyperimmune globulin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection
• Study Start Date: November 2011
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2015

Arms and Interventions

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 Name: 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	Biological: CMV hyperimmune globulin; 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant; Other Name: Cytogam; Drug: Valganciclovir; valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant; Other Name: Valcyte

Outcome Measures

Primary Outcome Measures :

1. Number of Patients With Late CMV Disease [ Time Frame: after 200 days post-transplant until 2 years post-transplant ]
   Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant

Secondary Outcome Measures :

1. Number of Patients With Early CMV Infection [ Time Frame: 100 days ]
2. Number of Patients With Cell Mediated Immunity [ Time Frame: 2 years ]
   Positive CMV quantiferon at last follow-up
3. Renal Function [ Time Frame: 6, 12, and 24 months after transplant ]
   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
4. Number of Participants With Acute Cellular and/or Antibody Mediated Rejection [ Time Frame: 2 years ]
5. Number of Participants With Opportunistic Infections [ Time Frame: 2 years ]
6. Number of Participants With Asymptomatic CMV Viremia [ Time Frame: 2 years ]
7. Number of Participants With CMV Seroconversions [ Time Frame: 2 years ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

CSL Behring

More Information

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01509404
• Other Study ID Numbers: Pro00009601
• First Posted: January 13, 2012
• Results First Posted: October 4, 2018
• Last Update Posted: October 4, 2018
• Last Verified: September 2018

Keywords provided by Medical University of South Carolina:

CMV; cytomegalovirus; transplant

Additional relevant MeSH terms:

Cytomegalovirus Infections; Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Valganciclovir; Antiviral Agents; Anti-Infective Agents