Phase 2
Completed N=17
Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients
EBV Viremia · CMV Viremia
Source: ClinicalTrials.gov NCT01329185 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Incidence of EBV or CMV Related Disease in Transplant Recipient — 2; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of EBV or CMV Related Disease in Transplant Recipient |
2; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01329185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.