NCT06538961 Immune Registry for BK in Kidney Transplant Recipients
| NCT ID | NCT06538961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | BK Virus Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-05-29 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Ambreen Azhar
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT06538961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying BK Virus Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06538961 currently recruiting?
Yes, NCT06538961 is actively recruiting participants. Contact the research team at ambreen.azhar@vcuhealth.org for enrollment information.
Where is the NCT06538961 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT06538961 clinical trial?
NCT06538961 is sponsored by Virginia Commonwealth University. The principal investigator is Ambreen Azhar at Virginia Commonwealth University. The trial plans to enroll 60 participants.