Immune Registry for BK in Kidney Transplant Recipients

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06538961
Status
Recruiting
Apply to this trial

Conditions

  • BK Virus Infection
  • Kidney Transplant; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood samples: Main Study group — OTHER
    the collection of blood samples at specified time points.
  • Data Collection — OTHER
    Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.
  • Urine Sample- Main Study group — OTHER
    -Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects
  • Urine sample- Sub-study group — OTHER
    \- Post-transplant monthly urine sample collection for 6 months in all subjects
  • Blood sample: Sub-study group — OTHER
    Monthly blood sample collection for 6 months

Study Details

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.

Key Dates

Start date
May 29, 2024
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Main study
    Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant.
  • Arm: 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.

Primary Outcome Measure

Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Ambreen Azhar
[email protected]
804-828-4104
Gelila Abebe
[email protected]
804-628-4969
Gaurav Gupta (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

By research site
Virginia Commonwealth University· Richmond, VA

Related Studies