CMV Viremia Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03443791 -
Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation
|
N/A | |
Enrolling by invitation |
NCT06263218 -
Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil
|
||
Recruiting |
NCT05432778 -
Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients
|
Phase 2 | |
Recruiting |
NCT04320303 -
CMV Infection and Immune Intervention After Transplantation
|
N/A | |
Recruiting |
NCT06011486 -
Expansion of Virus-Specific Lymphocytes for Cell Therapy
|
Phase 1 | |
Completed |
NCT04018261 -
Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT04298502 -
The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human
|
||
Recruiting |
NCT03798301 -
Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells
|
Phase 1 | |
No longer available |
NCT03010332 -
Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
|