Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients
Condition: EBV Viremia; CMV Viremia
MeSH terms: Viremia
Intervention: Valganciclovir; Placebo
Intervention description: Valganciclovir 450mg twice a day for 14 days prior to transplant date; 1 capsule twice a day for 14 days prior to transplant date
Intervention MeSH terms: Valganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: EBV Viremia in posttransplant kidney recipients; CMV viremia in posttransplant kidney recipients

Summary:

      The aim of our study is to reduce viral (CMV and EBV) transmission from donor to recipient.
      The discovery that anti-retroviral therapy to mothers with HIV reduced transmission of the
      virus to their babies was pivotal to the prevention of AIDS and so along the same lines the
      investigators will test the hypothesis that 14 days of the anti-viral Valganciclovir (VAL) to
      kidney donors prior to the transplant compared to placebo will reduce EBV and CMV viremia in
      the 1st year posttransplant in pediatric kidney recipients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Any person approved as a kidney transplant donor with a recipient who has never
             undergone a previous transplantation

          -  Kidney transplant donor must be 18 years old or older

          -  The kidney transplant donor must be positive for CMV IgG and / or EBV IgG

          -  The donor must be to a recipient that is discordantly seronegative for the virus for
             which the donor is seropositive (D+ R-)

          -  They must have provided signed informed consent

          -  The potential donors must be willing to contribute samples of blood and oral washings
             at regular intervals

          -  The potential donor must state willingness to use effective contraception during
             treatment and 30 days following receiving the study drug/placebo

          -  All females must have a negative pregnancy test

          -  Person must have estimated creatinine clearance (Cockcroft and Gault method) >= 60
             ml/min

          -  Person must have Absolute neutrophil count >= 1000 cells/uL

          -  Person must have Platelets >= 100,000/uL

          -  Person must have Hemoglobin >= 9.5 g/dL

        Exclusion criteria:

          -  Any potential kidney transplant donor who is seronegative for both CMV & EBV IgG

          -  Any potential kidney transplant donor who is receiving or have received anti-herpes
             medication in the past week

          -  Any potential kidney transplant donor to a recipient who has received a previous solid
             organ transplant

          -  Any potential kidney transplant donor who is immunosuppressed due to medical disease
             and/or immunosuppressive or immunomodulating medications

          -  Any potential kidney transplant donor who is breast feeding during the study

          -  Any potential kidney transplant donor who is on corticosteroids