Trial Outcomes & Findings for Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients (NCT NCT01329185)

Results Overview

Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

At least 1 year

Results posted on

2019-11-01

Participant milestones
Measure	Placebo Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date Placebo: 1 capsule twice a day for 14 days prior to transplant date	Valganciclovir Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date
Overall Study STARTED	10	7
Overall Study CMV Disease	1	0
Overall Study PTLD	1	0
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients

Baseline characteristics by cohort
Measure	Placebo n=10 Participants Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date Placebo: 1 capsule twice a day for 14 days prior to transplant date	Valganciclovir n=7 Participants Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date	Total n=17 Participants Total of all reporting groups
Age, Continuous	43.4 years n=5 Participants	47 years n=7 Participants	44.8 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

Timeframe: At least 1 year

Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.

Outcome measures
Measure	Placebo n=10 Participants Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date Placebo: 1 capsule twice a day for 14 days prior to transplant date	Valganciclovir n=7 Participants Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date
Incidence of EBV or CMV Related Disease in Transplant Recipient	2 participants	0 participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Placebo n=10 participants at risk Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date Placebo: 1 capsule twice a day for 14 days prior to transplant date	Valganciclovir n=7 participants at risk Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date
General disorders Headache	10.0% 1/10 • Number of events 1	0.00% 0/7
Skin and subcutaneous tissue disorders Itching	10.0% 1/10 • Number of events 1	0.00% 0/7

University of Minnesota

Phone: 6126262922