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Trial record 40 of 101 for:    Valcyte

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

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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:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cytomegalovirus Disease
Interventions Drug: Valganciclovir
Biological: CMV hyperimmune globulin
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Valcyte - Kidney Transplant Valcyte Then Cytogam - Kidney Transplant Valcyte - Liver Transplant Valcyte Then Cytogam - Liver Transplant Total
Hide Arm/Group Description Subjects who received a kidney transplant and assigned to the Valcyte only Treatment arm. Subjects who received a kidney transplant and assigned to the Valcyte then CytogamTreatment arm. Subjects who received a liver transplant and assigned to the Valcyte only Treatment arm. Subjects who received a liver transplant and assigned to the Valcyte then Cytogam Treatment arm. Total of all reporting groups
Overall Number of Baseline Participants 17 15 3 5 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 15 participants 3 participants 5 participants 40 participants
51
(21 to 71)
54
(26 to 69)
58
(27 to 58)
60
(48 to 61)
56
(21 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 3 participants 5 participants 40 participants
Female
4
  23.5%
4
  26.7%
2
  66.7%
0
   0.0%
10
  25.0%
Male
13
  76.5%
11
  73.3%
1
  33.3%
5
 100.0%
30
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 3 participants 5 participants 40 participants
American Indian or Alaska Native
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  41.2%
6
  40.0%
0
   0.0%
0
   0.0%
13
  32.5%
White
9
  52.9%
9
  60.0%
3
 100.0%
5
 100.0%
26
  65.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Retransplant  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 3 participants 5 participants 40 participants
2
  11.8%
2
  13.3%
0
   0.0%
0
   0.0%
4
  10.0%
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 17 participants 15 participants 3 participants 5 participants 40 participants
71  (20) 88  (21) 84  (13) 91  (25) 84  (20)
Pre-emptive   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 0 participants 0 participants 32 participants
3
  17.6%
1
   6.7%
0 0
4
  12.5%
[1]
Measure Analysis Population Description: Pre-Emptive applies only to kidney transplant patients. Pre-emptive values were obtained by counting the number of patients who were not on dialysis prior to their kidney transplant.
1.Primary Outcome
Title Number of Patients With Late CMV Disease
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Patients With Early CMV Infection
Hide Description [Not Specified]
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.0%
1
   5.0%
3.Secondary Outcome
Title Number of Patients With Cell Mediated Immunity
Hide Description Positive CMV quantiferon at last follow-up
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
8
  40.0%
13
  65.0%
4.Secondary Outcome
Title Renal Function
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Mean (Full Range)
Unit of Measure: mL/min/1.73m^2
GFR at 180 Days
57
(22 to 123)
53
(30 to 78)
GFR at 1 year
59
(26 to 171)
54
(31 to 71)
GFR at 2 years
59
(29 to 143)
55
(20 to 72)
5.Secondary Outcome
Title Number of Participants With Acute Cellular and/or Antibody Mediated Rejection
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
6
  30.0%
6.Secondary Outcome
Title Number of Participants With Opportunistic Infections
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
17
  85.0%
19
  95.0%
7.Secondary Outcome
Title Number of Participants With Asymptomatic CMV Viremia
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
5
  25.0%
8.Secondary Outcome
Title Number of Participants With CMV Seroconversions
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description:

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
13
  65.0%
19
  95.0%
Time Frame up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valcyte Valcyte Then Cytogam
Hide Arm/Group Description

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

Valganciclovir: Valcyte per package insert guidelines 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

CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

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

All-Cause Mortality
Valcyte Valcyte Then Cytogam
Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Valcyte Valcyte Then Cytogam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      4/20 (20.00%)    
Infections and infestations     
CMV disease   3/20 (15.00%)  3 4/20 (20.00%)  4
Renal and urinary disorders     
Graft loss   1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Valcyte Valcyte Then Cytogam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/20 (80.00%)      20/20 (100.00%)    
Blood and lymphatic system disorders     
Leukopenia   9/20 (45.00%)  9 10/20 (50.00%)  10
Thrombocytopenia   2/20 (10.00%)  2 1/20 (5.00%)  1
Infections and infestations     
Candidiasis   0/20 (0.00%)  0 3/20 (15.00%)  3
Renal and urinary disorders     
BK infection   3/20 (15.00%)  3 5/20 (25.00%)  5
Acute rejection   2/20 (10.00%)  2 6/20 (30.00%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: James Fleming
Organization: Medical University of South Carolina
Phone: 843-792-0312
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01509404     History of Changes
Other Study ID Numbers: Pro00009601
First Submitted: January 10, 2012
First Posted: January 13, 2012
Results First Submitted: February 9, 2018
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018