EBV ViremiaPhase 2NCT01329185
Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients
A Phase 2 study testing Valganciclovir in people with EBV Viremia and CMV Viremia, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- EBV Viremia, CMV Viremia
- What is being tested?
- Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2014
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
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.
Read the detailed description
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.
- Conditions
- EBV Viremia, CMV Viremia
- Being tested
- Valganciclovir, Placebo
- Keywords
- EBV Viremia in posttransplant kidney recipients, CMV viremia in posttransplant kidney recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Valganciclovir 450mg twice a day for 14 days prior to transplant date
PlaceboDrug
1 capsule twice a day for 14 days prior to transplant date
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
| Valganciclovir | Experimental | 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 Receives: Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of EBV or CMV Related Disease in Transplant Recipient
Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.
Measured: At least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EBV ViremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priya Verghese, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329185
- Sponsor's protocol ID
- 1012M93572
- Status last verified
- Oct 2019
- First submitted
- 1 Apr 2011
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
PubMed 38700045Verghese PS, Evans MD, Hanson A, Hathi J, Chinnakotla S, Matas A, Balfour HH Jr. Valacyclovir or valganciclovir for cytomegalovirus prophylaxis: A randomized controlled trial in adult and pediatric kidney transplant recipients. J Clin Virol. 2024 Jun;172:105678. doi: 10.1016/j.jcv.2024.105678. Epub 2024 Apr 22.
PubMed 38688164