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

Primary Purpose

Cytomegalovirus Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Valganciclovir

CMV hyperimmune globulin

Valganciclovir

About this trial

This is an interventional prevention trial for Cytomegalovirus Disease focused on measuring CMV, cytomegalovirus, transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Valcyte

Valcyte then Cytogam

Arm Description

valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Patients With Early CMV Infection

Number of Patients With Cell Mediated Immunity

Positive CMV quantiferon at last follow-up

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

Number of Participants With Acute Cellular and/or Antibody Mediated Rejection

Number of Participants With Opportunistic Infections

Number of Participants With Asymptomatic CMV Viremia

Number of Participants With CMV Seroconversions

Full Information

NCT ID

NCT01509404

First Posted

January 10, 2012

Last Updated

September 6, 2018

Sponsor

Medical University of South Carolina

Collaborators

CSL Behring

1. Study Identification

Unique Protocol Identification Number

NCT01509404

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

Collaborators

CSL Behring

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Disease

Keywords

CMV, cytomegalovirus, transplant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valcyte

Arm Type

Active Comparator

Arm Description

valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Arm Title

Valcyte then Cytogam

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Valganciclovir

Other Intervention Name(s)

Valcyte

Intervention Description

Valcyte per package insert guidelines for 200 days post transplant

Intervention Type

Biological

Intervention Name(s)

CMV hyperimmune globulin

Other Intervention Name(s)

Cytogam

Intervention Description

100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

Intervention Type

Drug

Intervention Name(s)

Valganciclovir

Other Intervention Name(s)

Valcyte

Intervention Description

valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Primary Outcome Measure Information:

Title

Number of Patients With Late CMV Disease

Description

Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant

Time Frame

after 200 days post-transplant until 2 years post-transplant

Secondary Outcome Measure Information:

Title

Number of Patients With Early CMV Infection

Time Frame

100 days

Title

Number of Patients With Cell Mediated Immunity

Description

Positive CMV quantiferon at last follow-up

Time Frame

2 years

Title

Renal Function

Description

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

Time Frame

6, 12, and 24 months after transplant

Title

Number of Participants With Acute Cellular and/or Antibody Mediated Rejection

Time Frame

2 years

Title

Number of Participants With Opportunistic Infections

Time Frame

2 years

Title

Number of Participants With Asymptomatic CMV Viremia

Time Frame

2 years

Title

Number of Participants With CMV Seroconversions

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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

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