Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Ambreen Azhar
ambreen.azhar@vcuhealth.org
804-828-4104
Backup
Gelila Abebe
gelila.abebe@vcuhealth.org
(804) 628-4969
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2026-05
Participants
Target number of participants: 60
Treatments
Main study
Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant.
Sub-study
Single organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia or those with difficult-to-treat BKV \> 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant.
Related Therapeutic Areas
Sponsors
Leads: Virginia Commonwealth University
Collaborators: Eurofins

This content was sourced from clinicaltrials.gov