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
  Purpose

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.


Condition Intervention Phase
EBV Viremia
CMV Viremia
Drug: Valganciclovir
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
1 capsule twice a day for 14 days prior to transplant date
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
Drug: Valganciclovir
Valganciclovir 450mg twice a day for 14 days prior to transplant date

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329185

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Priya Verghese, MD, MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01329185     History of Changes
Other Study ID Numbers: PV-777
Study First Received: April 1, 2011
Results First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
EBV Viremia in posttransplant kidney recipients
CMV viremia in posttransplant kidney recipients

Additional relevant MeSH terms:
Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014