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Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients

Primary Purpose

EBV Viremia, CMV Viremia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Valganciclovir
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for EBV Viremia focused on measuring EBV Viremia in posttransplant kidney recipients, CMV viremia in posttransplant kidney recipients

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Valganciclovir

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of EBV or CMV Related Disease in Transplant Recipient
Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2011
Last Updated
October 30, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01329185
Brief Title
Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EBV Viremia, CMV Viremia
Keywords
EBV Viremia in posttransplant kidney recipients, CMV viremia in posttransplant kidney recipients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Valganciclovir
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Valganciclovir
Intervention Description
Valganciclovir 450mg twice a day for 14 days prior to transplant date
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule twice a day for 14 days prior to transplant date
Primary Outcome Measure Information:
Title
Incidence of EBV or CMV Related Disease in Transplant Recipient
Description
Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.
Time Frame
At least 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Verghese, MD, MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients

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