Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01329185
First received: April 1, 2011
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: May 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: EBV Viremia
CMV Viremia
Interventions: Drug: Valganciclovir
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Placebo     Valganciclovir  
STARTED     10     7  
CMV Disease     1     0  
PTLD     1     0  
COMPLETED     10     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible kidney transplant donors were enrolled at the University of Minnesota Medical Center.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Placebo     Valganciclovir     Total  
Number of Participants  
[units: participants]
  10     7     17  
Age [1]
[units: years]
Mean ( Full Range )
  43.4  
  ( 30.7 to 54.5 )  
  47  
  ( 29.7 to 66.6 )  
  44.8  
  ( 29.7 to 66.6 )  
Gender  
[units: participants]
     
Female     7     6     13  
Male     3     1     4  
Region of Enrollment [2]
[units: participants]
     
United States     10     7     17  
[1] Donor Age at Transplant
[2] Donors were recruited from the University of Minnesota Medical Center



  Outcome Measures

1.  Primary:   Incidence of EBV or CMV Related Disease in Transplant Recipient   [ Time Frame: At least 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

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
e-mail: pverghes@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01329185     History of Changes
Other Study ID Numbers: PV-777
Study First Received: April 1, 2011
Results First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board