Trial Outcomes & Findings for Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection (NCT NCT01509404)
NCT ID: NCT01509404
Last Updated: 2018-10-04
Results Overview
Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
after 200 days post-transplant until 2 years post-transplant
Results posted on
2018-10-04
Participant Flow
Participant milestones
| Measure |
Valcyte
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
|
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
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 Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Valcyte - Kidney Transplant
n=17 Participants
Subjects who received a kidney transplant and assigned to the Valcyte only Treatment arm.
|
Valcyte Then Cytogam - Kidney Transplant
n=15 Participants
Subjects who received a kidney transplant and assigned to the Valcyte then CytogamTreatment arm.
|
Valcyte - Liver Transplant
n=3 Participants
Subjects who received a liver transplant and assigned to the Valcyte only Treatment arm.
|
Valcyte Then Cytogam - Liver Transplant
n=5 Participants
Subjects who received a liver transplant and assigned to the Valcyte then Cytogam Treatment arm.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
n=17 Participants
|
54 years
n=15 Participants
|
58 years
n=3 Participants
|
60 years
n=5 Participants
|
56 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=17 Participants
|
4 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=17 Participants
|
11 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=17 Participants
|
6 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=17 Participants
|
9 Participants
n=15 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
26 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
|
Retransplant
|
2 Participants
n=17 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=40 Participants
|
|
Weight (kg)
|
71 kg
STANDARD_DEVIATION 20 • n=17 Participants
|
88 kg
STANDARD_DEVIATION 21 • n=15 Participants
|
84 kg
STANDARD_DEVIATION 13 • n=3 Participants
|
91 kg
STANDARD_DEVIATION 25 • n=5 Participants
|
84 kg
STANDARD_DEVIATION 20 • n=40 Participants
|
|
Pre-emptive
|
3 Participants
n=17 Participants • 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 Participants
n=15 Participants • 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.
|
0 Participants
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.
|
0 Participants
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.
|
4 Participants
n=32 Participants • 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.
|
PRIMARY outcome
Timeframe: after 200 days post-transplant until 2 years post-transplantNumber of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant
Outcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Number of Patients With Late CMV Disease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Number of Patients With Early CMV Infection
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPositive CMV quantiferon at last follow-up
Outcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Number of Patients With Cell Mediated Immunity
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6, 12, and 24 months after transplantRenal 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
Outcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Renal Function
GFR at 180 Days
|
57 mL/min/1.73m^2
Interval 22.0 to 123.0
|
53 mL/min/1.73m^2
Interval 30.0 to 78.0
|
|
Renal Function
GFR at 1 year
|
59 mL/min/1.73m^2
Interval 26.0 to 171.0
|
54 mL/min/1.73m^2
Interval 31.0 to 71.0
|
|
Renal Function
GFR at 2 years
|
59 mL/min/1.73m^2
Interval 29.0 to 143.0
|
55 mL/min/1.73m^2
Interval 20.0 to 72.0
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Number of Participants With Acute Cellular and/or Antibody Mediated Rejection
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Number of Participants With Opportunistic Infections
|
17 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Number of Participants With Asymptomatic CMV Viremia
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Valcyte
n=20 Participants
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
|
Valcyte Then Cytogam
n=20 Participants
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
|
|---|---|---|
|
Number of Participants With CMV Seroconversions
|
13 Participants
|
19 Participants
|
Adverse Events
Valcyte
Serious events: 4 serious events
Other events: 16 other events
Deaths: 1 deaths
Valcyte Then Cytogam
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valcyte
n=20 participants at risk
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
|
Valcyte Then Cytogam
n=20 participants at risk
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
|
|---|---|---|
|
Infections and infestations
CMV disease
|
15.0%
3/20 • Number of events 3 • up to 2 years
|
20.0%
4/20 • Number of events 4 • up to 2 years
|
|
Renal and urinary disorders
Graft loss
|
5.0%
1/20 • Number of events 1 • up to 2 years
|
0.00%
0/20 • up to 2 years
|
Other adverse events
| Measure |
Valcyte
n=20 participants at risk
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
|
Valcyte Then Cytogam
n=20 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
45.0%
9/20 • Number of events 9 • up to 2 years
|
50.0%
10/20 • Number of events 10 • up to 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
2/20 • Number of events 2 • up to 2 years
|
5.0%
1/20 • Number of events 1 • up to 2 years
|
|
Renal and urinary disorders
BK infection
|
15.0%
3/20 • Number of events 3 • up to 2 years
|
25.0%
5/20 • Number of events 5 • up to 2 years
|
|
Infections and infestations
Candidiasis
|
0.00%
0/20 • up to 2 years
|
15.0%
3/20 • Number of events 3 • up to 2 years
|
|
Renal and urinary disorders
Acute rejection
|
10.0%
2/20 • Number of events 2 • up to 2 years
|
30.0%
6/20 • Number of events 6 • up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place