Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||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|
- 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.
|Study Start Date:||June 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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
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 450mg twice a day for 14 days prior to transplant date
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329185
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Priya Verghese, MD, MPH||University of Minnesota - Clinical and Translational Science Institute|