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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

April 1, 2011
May 19, 2014
June 2011
February 2013   (final data collection date for primary outcome measure)
Incidence of EBV or CMV Related Disease in Transplant Recipient [ Time Frame: At least 1 year ] [ Designated as safety issue: No ]
Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.
Incidence of EBV/CMV viremia in transplant recipient [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Incidence of EBV or CMV viremia in the transplant recipients defined as any patient who develops detectable virus in their blood, by real-time PCR assay and magnitude of viremia measured by area under the viral load-time curve (AUC) of recipients who become viremic with EBV and / or CMV in the first year posttransplant.
Complete list of historical versions of study NCT01329185 on ClinicalTrials.gov Archive Site
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Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients
Double Blinded Placebo Controlled Study to Assess Clinical and Antiviral Activity of Valganciclovir (VAL) in Solid Organ Transplant Donors to Reduce Viral Transmission From Donor to Recipient

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.

The potency of new immunosuppressive agents has reduced the risk of the body's immune system rejecting a transplanted kidney. However, this has come with a price. Kidney transplant recipients now face a higher risk of serious infections and related malignancies.

Viral infections are a significant cause of posttransplant morbidity and mortality and two of the herpes viruses have the greatest impact: Epstein-Barr virus (EBV) and Cytomegalovirus (CMV). CMV disease can manifest posttransplant as fever, leukopenia, or mild to severe organ involvement (including pneumonitis, hepatitis, pancreatitis, colitis, meningoencephalitis, and rarely myocarditis). EBV can present posttransplant as infectious mononucleosis syndrome, hepatitis and, in the worse case scenario, a potentially fatal lymphoproliferative disorder called Post-Transplant Lymphoproliferative Disease (PTLD). Moreover, subclinical CMV and/or EBV viremia have been associated with deterioration in kidney function in kidney transplant recipients. Thus, the potential negative impact of these viruses on the lives of transplant recipients is profound and, unfortunately, the complications of these post-transplant viral infections are common and occur despite standard antiviral prophylaxis in the first year posttransplant.

These viral infections, in most instances, originate from the donor organ where these viruses reside in a dormant state, counterbalanced by the donor's healthy immune system. Upon transplantation into the recipient, whose immune system is then severely suppressed by anti-rejection drugs, these viruses become activated, often leading to the above described complications.

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. We aim to enroll 20 donor-recipient pairs.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • EBV Viremia
  • CMV Viremia
  • Drug: Valganciclovir
    Valganciclovir 450mg twice a day for 14 days prior to transplant date
  • Drug: Placebo
    1 capsule twice a day for 14 days prior to transplant date
  • Placebo Comparator: 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
    Intervention: Drug: Placebo
  • Experimental: 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
    Intervention: Drug: Valganciclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
17
June 2014
February 2013   (final data collection date for primary outcome measure)

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
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01329185
PV-777
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Priya Verghese, MD, MPH University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP