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Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients

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ClinicalTrials.gov Identifier: NCT01329185
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : June 20, 2014
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions EBV Viremia
CMV Viremia
Interventions Drug: Valganciclovir
Drug: Placebo
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 10 7
CMV Disease 1 0
PTLD 1 0
Completed 10 7
Not Completed 0 0
Arm/Group Title Placebo Valganciclovir Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 10 7 17
Hide Baseline Analysis Population Description
Eligible kidney transplant donors were enrolled at the University of Minnesota Medical Center.
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 7 participants 17 participants
43.4
(30.7 to 54.5)
47
(29.7 to 66.6)
44.8
(29.7 to 66.6)
[1]
Measure Description: Donor Age at Transplant
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 17 participants
Female
7
  70.0%
6
  85.7%
13
  76.5%
Male
3
  30.0%
1
  14.3%
4
  23.5%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 7 participants 17 participants
10 7 17
[1]
Measure Description: Donors were recruited from the University of Minnesota Medical Center
1.Primary Outcome
Title Incidence of EBV or CMV Related Disease in Transplant Recipient
Hide Description Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.
Time Frame At least 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 10 7
Measure Type: Number
Unit of Measure: participants
2 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description

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

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

All-Cause Mortality
Placebo Valganciclovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Valganciclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Valganciclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      0/7 (0.00%)    
General disorders     
Headache   1/10 (10.00%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders     
Itching   1/10 (10.00%)  1 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
Study was unblinded 2 months following the enrollment of the final donor, when a recipient developed post-transplant lymphoproliferative disorder with evidence of EBV infection at the single cell level by detection of EBV encoded small nuclear RNA.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Priya Verghese, Director of Pediatric Kidney Transplantation
Organization: University of Minnesota
Phone: 6126262922 ext 0
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01329185     History of Changes
Other Study ID Numbers: PV-777
First Submitted: April 1, 2011
First Posted: April 5, 2011
Results First Submitted: May 19, 2014
Results First Posted: June 20, 2014
Last Update Posted: June 23, 2015