Trial Outcomes & Findings for ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation (NCT NCT01972035)
NCT ID: NCT01972035
Last Updated: 2022-04-12
Results Overview
In infectious mononucleosis intervention trials, two weeks of valA therapy resulted in a statistically significant reduction in oral EBV shedding, accompanied by a clinical benefit, and valA is currently used for the therapy of severe cases of infectious mononucleosis in the community. ValA has also been shown to reduce the incidence and delay the onset of CMV disease in both CMV seronegative patients (P\<0.001) and CMV seropositive patients (P=0.03). Therefore we hypothesize that the anti-EBV and anti-CMV effects of valA will be equal to or more effective than valG in reducing post-kidney transplant EBV and CMV viremia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
First year post-kidney transplant
Results posted on
2022-04-12
Participant Flow
Participant milestones
| Measure |
ValAcyclovir
Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valacyclovir: Experimental Arm
|
ValGanciclovir
Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valganciclovir: Standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
71
|
|
Overall Study
COMPLETED
|
27
|
44
|
|
Overall Study
NOT COMPLETED
|
39
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation
Baseline characteristics by cohort
| Measure |
ValAcyclovir
n=66 Participants
Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valacyclovir: Experimental Arm
|
ValGanciclovir
n=71 Participants
Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valganciclovir: Standard of care
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
71 participants
n=7 Participants
|
137 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First year post-kidney transplantIn infectious mononucleosis intervention trials, two weeks of valA therapy resulted in a statistically significant reduction in oral EBV shedding, accompanied by a clinical benefit, and valA is currently used for the therapy of severe cases of infectious mononucleosis in the community. ValA has also been shown to reduce the incidence and delay the onset of CMV disease in both CMV seronegative patients (P\<0.001) and CMV seropositive patients (P=0.03). Therefore we hypothesize that the anti-EBV and anti-CMV effects of valA will be equal to or more effective than valG in reducing post-kidney transplant EBV and CMV viremia.
Outcome measures
| Measure |
ValAcyclovir
n=66 Participants
Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valacyclovir: Experimental Arm
|
ValGanciclovir
n=71 Participants
Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valganciclovir: Standard of care
|
|---|---|---|
|
Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.
EBV Viremia
|
16 Participants
|
20 Participants
|
|
Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.
CMV Viremia
|
8 Participants
|
4 Participants
|
|
Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.
BK Viremia
|
5 Participants
|
11 Participants
|
|
Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.
PTLD/EBV Disease
|
2 Participants
|
1 Participants
|
|
Compare Incidence, Duration and Magnitude of CMV and EBV Viremia in Kidney Transplant Recipients Receiving valA vs. valG.
None
|
35 Participants
|
35 Participants
|
Adverse Events
ValAcyclovir
Serious events: 52 serious events
Other events: 64 other events
Deaths: 0 deaths
ValGanciclovir
Serious events: 50 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ValAcyclovir
n=66 participants at risk
Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valacyclovir: Experimental Arm
|
ValGanciclovir
n=71 participants at risk
Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valganciclovir: Standard of care
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Problems
|
4.5%
3/66 • Number of events 3 • 1 year following intervention
|
4.2%
3/71 • Number of events 3 • 1 year following intervention
|
|
Skin and subcutaneous tissue disorders
Ascites
|
1.5%
1/66 • Number of events 1 • 1 year following intervention
|
1.4%
1/71 • Number of events 2 • 1 year following intervention
|
|
Infections and infestations
Bacterial Infection
|
1.5%
1/66 • Number of events 1 • 1 year following intervention
|
2.8%
2/71 • Number of events 2 • 1 year following intervention
|
|
Investigations
Biopsy
|
7.6%
5/66 • Number of events 5 • 1 year following intervention
|
4.2%
3/71 • Number of events 3 • 1 year following intervention
|
|
Endocrine disorders
Blood sugar concerns
|
1.5%
1/66 • Number of events 1 • 1 year following intervention
|
2.8%
2/71 • Number of events 2 • 1 year following intervention
|
|
Respiratory, thoracic and mediastinal disorders
Breathing concerns
|
1.5%
1/66 • Number of events 2 • 1 year following intervention
|
2.8%
2/71 • Number of events 3 • 1 year following intervention
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66 • Number of events 1 • 1 year following intervention
|
5.6%
4/71 • Number of events 4 • 1 year following intervention
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
4/66 • Number of events 4 • 1 year following intervention
|
4.2%
3/71 • Number of events 3 • 1 year following intervention
|
|
Immune system disorders
Donor source antibodies
|
6.1%
4/66 • Number of events 4 • 1 year following intervention
|
1.4%
1/71 • Number of events 1 • 1 year following intervention
|
|
Renal and urinary disorders
Elevated Creatinine
|
31.8%
21/66 • Number of events 21 • 1 year following intervention
|
29.6%
21/71 • Number of events 23 • 1 year following intervention
|
|
Immune system disorders
Fever
|
10.6%
7/66 • Number of events 9 • 1 year following intervention
|
9.9%
7/71 • Number of events 9 • 1 year following intervention
|
|
Surgical and medical procedures
G Tube Concerns
|
1.5%
1/66 • Number of events 3 • 1 year following intervention
|
4.2%
3/71 • Number of events 9 • 1 year following intervention
|
|
Cardiac disorders
Heart concerns
|
9.1%
6/66 • Number of events 7 • 1 year following intervention
|
7.0%
5/71 • Number of events 5 • 1 year following intervention
|
|
Renal and urinary disorders
Hematuria
|
3.0%
2/66 • Number of events 2 • 1 year following intervention
|
2.8%
2/71 • Number of events 2 • 1 year following intervention
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.1%
4/66 • Number of events 4 • 1 year following intervention
|
2.8%
2/71 • Number of events 2 • 1 year following intervention
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/66 • Number of events 2 • 1 year following intervention
|
0.00%
0/71 • 1 year following intervention
|
|
Psychiatric disorders
Mental Concerns
|
0.00%
0/66 • 1 year following intervention
|
2.8%
2/71 • Number of events 4 • 1 year following intervention
|
|
General disorders
Severe Pain
|
13.6%
9/66 • Number of events 11 • 1 year following intervention
|
5.6%
4/71 • Number of events 4 • 1 year following intervention
|
|
Vascular disorders
Thrombosis
|
4.5%
3/66 • Number of events 3 • 1 year following intervention
|
5.6%
4/71 • Number of events 4 • 1 year following intervention
|
|
Immune system disorders
Upper Respiratory Infection
|
10.6%
7/66 • Number of events 9 • 1 year following intervention
|
8.5%
6/71 • Number of events 10 • 1 year following intervention
|
|
Renal and urinary disorders
Urination Concerns
|
4.5%
3/66 • Number of events 4 • 1 year following intervention
|
4.2%
3/71 • Number of events 3 • 1 year following intervention
|
|
Renal and urinary disorders
Urinary Tract Infection
|
9.1%
6/66 • Number of events 10 • 1 year following intervention
|
15.5%
11/71 • Number of events 19 • 1 year following intervention
|
|
General disorders
Other
|
15.2%
10/66 • Number of events 12 • 1 year following intervention
|
14.1%
10/71 • Number of events 12 • 1 year following intervention
|
Other adverse events
| Measure |
ValAcyclovir
n=66 participants at risk
Kidney recipients who give informed consent will be randomly assigned to receive ValA or ValG in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valacyclovir: Experimental Arm
|
ValGanciclovir
n=71 participants at risk
Kidney recipients who give informed consent will be randomly assigned to receive ValG or ValA in a 1:1 ratio. Duration of therapy is 3-12 months depending on risk and age of recipient. Dosing is based on glomerular filtration rate.
Valganciclovir: Standard of care
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
31.8%
21/66 • 1 year following intervention
|
28.2%
20/71 • 1 year following intervention
|
|
Gastrointestinal disorders
Diarrhea
|
65.2%
43/66 • 1 year following intervention
|
64.8%
46/71 • 1 year following intervention
|
|
Gastrointestinal disorders
Nausea
|
37.9%
25/66 • 1 year following intervention
|
39.4%
28/71 • 1 year following intervention
|
|
Gastrointestinal disorders
Emesis
|
34.8%
23/66 • 1 year following intervention
|
43.7%
31/71 • 1 year following intervention
|
|
General disorders
Fatigue
|
12.1%
8/66 • 1 year following intervention
|
72.7%
8/11 • 1 year following intervention
|
|
Immune system disorders
Alopecia
|
1.5%
1/66 • 1 year following intervention
|
4.2%
3/71 • 1 year following intervention
|
|
Blood and lymphatic system disorders
Anemia
|
97.0%
64/66 • 1 year following intervention
|
98.6%
70/71 • 1 year following intervention
|
|
Hepatobiliary disorders
Abnormal LFTs
|
3.0%
2/66 • 1 year following intervention
|
11.3%
8/71 • 1 year following intervention
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.6%
40/66 • 1 year following intervention
|
64.8%
46/71 • 1 year following intervention
|
|
General disorders
Headache
|
9.1%
6/66 • 1 year following intervention
|
15.5%
11/71 • 1 year following intervention
|
|
Nervous system disorders
Peripheral neuropathy
|
4.5%
3/66 • 1 year following intervention
|
5.6%
4/71 • 1 year following intervention
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
3/66 • 1 year following intervention
|
11.3%
8/71 • 1 year following intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place