NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Virginia Commonwealth University
Conditions: BK Virus Infection, Kidney Transplant; Complications
Interventions: Blood samples: Main Study group, Data Collection, Urine Sample- Main Study group, Urine sample- Sub-study group, Blood sample: Sub-study group
Countries: United States
Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Inclusion Criteria: * Adult (\>18 years old) male and female, deceased donor KT recipients * Will include single organ transplants. * Each participant must also have recently been diagnosed with BK viremia. * In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \> 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). Exclusion Criteria: * Prisoners will not be included in the study * Multi-organ transplants and pregnant women
- Richmond, Virginia, United States