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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01509404
First received: January 10, 2012
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Cytomegalovirus Disease
Drug: Valganciclovir
Biological: CMV hyperimmune globulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • CMV infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Incidence of any clinically significant late CMV infection: including disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days after 200 days post-transplant


Secondary Outcome Measures:
  • Early CMV infection [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • cell mediated immunity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • renal function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Incidence and severity of acute cellular and/or antibody mediated rejection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of post-transplant diabetes mellitus [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence and severity of opportunistic infections [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of asymptomatic CMV viremia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of CMV seroconversion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Drug cost comparison [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509404

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

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01509404     History of Changes
Other Study ID Numbers: Pro00009601
Study First Received: January 10, 2012
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
CMV
cytomegalovirus
transplant

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014